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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06940596
Registration number
NCT06940596
Ethics application status
Date submitted
31/03/2025
Date registered
23/04/2025
Date last updated
10/07/2025
Titles & IDs
Public title
Exclude or Expose in Irritable Bowel Syndrome: What Works for Whom and How?
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Scientific title
Exclude or Expose in Irritable Bowel Syndrome: What Works for Whom, and How? A Randomized Controlled Trial of Internet-Delivered FODMAP Diet Versus Exposure-Based Cognitive Behavioral Therapy
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Secondary ID [1]
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2024
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Secondary ID [2]
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CT31293
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Irritable Bowel Syndrome (IBS)
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Intestinal Diseases
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Gastrointestinal Disease
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - FODMAP Diet
BEHAVIORAL - Exposure-based Cognitive Behavioral Therapy
Experimental: FODMAP Diet - Fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) Diet is a 12-week online intervention with dietitian support.
Experimental: Exposure-based Cognitive Behavioral Therapy (E-CBT) - Exposure-based Cognitive Behavioral Therapy is a 12-week online intervention with psychologist support.
Other interventions: FODMAP Diet
The intervention is an online diet program. The diet is the low fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet. It is a 3-phase diet which involves: 1.Phase 1 FODMAP restriction: restrict foods high or moderate in FODMAPs and swap these for low FODMAP alternatives; 2. Phase 2 FODMAP reintroduction: continue to follow a low FODMAP diet and complete a series of food challenges to understand which foods and FODMAPs are tolerated and which trigger symptoms; 3. Phase 3 FODMAP personalization: include well-tolerated foods and FODMAPs back into the diet, and restrict poorly tolerated foods and FODMAPs to a level needed to maintain symptom relief. The online FODMAP program is a self-directed diet program with support from an online clinician (Accredited Practicing Dietitian \[APD\]). The content is delivered over 12 weeks. After each module participants will complete homework activities and questions and submit them to the dietitian for feedback.
BEHAVIORAL: Exposure-based Cognitive Behavioral Therapy
The intervention is an online behavioral therapy program. The behavioral therapy is Exposure-based Cognitive Behavioral Therapy (E-CBT) Program. The E-CBT program is organised into six steps to be completed over 12 weekly modules with support from an online clinician (Psychologist). The first step contains a rationale for the treatment and instructions on self-observation. Steps 2, 3 and 4 contain a presentation of a psychological model of IBS and continued self-observation exercises. The fifth step covers exposure exercises, divided into three categories; (1) exercises that provoke symptoms, (2) abolishment of behaviors that serve to control symptoms, (3) exposure to situations where symptoms were unwanted. The final step (Step 6) includes how to handle relapses into avoidance behaviors and how to maintain a widened behavioral repertoire. After each module participants will be directed to complete homework activities and questions and submit them to the psychologist for feedback.
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Intervention code [1]
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Other interventions
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Intervention code [2]
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BEHAVIORAL
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Gastrointestinal Symptom Rating Scale-Irritable Bowel Syndrome (GSRS-IBS )
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Assessment method [1]
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The GSRS-IBS is a 13-item measure of IBS symptom severity to reflect the last 7 days. The items are scored between 1 (no discomfort at all) and 7 (very severe discomfort), rendering a total score between 13 and 91.
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Timepoint [1]
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Measured weekly between baseline (prior to intervention) and after intervention completed (week 12).
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Secondary outcome [1]
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Change from baseline in Gastrointestinal Symptom Rating Scale-Irritable Bowel Syndrome (GSRS-IBS)
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Assessment method [1]
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The GSRS-IBS is a 13-item measure of IBS symptom severity to reflect the last 7 days. The items are scored between 1 (no discomfort at all) and 7 (very severe discomfort), rendering a total score between 13 and 91.
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Timepoint [1]
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Baseline and 3-and 6 month follow up time points after intervention completed (week 12).
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Secondary outcome [2]
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Change from baseline in Irritable Bowel Syndrome - Symptom Severity Score (IBS-SSS) questionnaire
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Assessment method [2]
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The IBS-SSS is a 5-item measure of the severity of IBS symptoms: frequency and severity of abdominal pain, severity of bloating, dissatisfaction with bowel habits and impact on life in general. Questions ask about IBS and gut symptoms during the past 7 days except question 4 which asks participants to enter the number of days they get pain in every 10. days. A total score ranging from 0 to 500. Mild, moderate and severe cases are indicated by scores of 75 to \<175, 175 to \<300 and \>300 respectively
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Timepoint [2]
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Baseline, after intervention completed (week 12), and at follow up time points of 3-and 6 months following the 12-week intervention.
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Secondary outcome [3]
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Change from baseline in IBS quality of life (IBS-QOL) questionnaire
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Assessment method [3]
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IBS-QOL is used to assess the impact on quality of life for patients with IBS and consists of 34 items scored between 1 and 5, resulting in a maximum score of 170.
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Timepoint [3]
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Baseline, after intervention completed (week 12), and at follow up time points of 3-and 6 months following the 12-week intervention.
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Secondary outcome [4]
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Change from baseline in Nine Item ARFID (Avoidant Restrictive Food Intake Disorder) Screen (NIAS) questionnaire
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Assessment method [4]
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NIAS is a 9-item measure of ARFID symptoms. The scale has 9 questions, scored from 0 (strongly disagree) to 5 (strongly agree) and summed into three subscales (fear of adverse consequences, lack of interest/appetite, and sensory sensitivity); each range = 0-15), with higher scores indicating greater severity.
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Timepoint [4]
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Baseline, after intervention completed (week 12), and at follow up time points of 3-and 6 months following the 12-week intervention.
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Secondary outcome [5]
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Change from baseline in Fear of Food Questionnaire (FFQ) questionnaire
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Assessment method [5]
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The Fear of Food Questionnaire (FFQ) is an 18-item measure of food-related fears averaged into five subscales (GI fears, food fears, food avoidance, social impairment, and distress/loss of pleasure) and a total score between 0 and 90 (each range = 0-5), with higher scores indicating greater food related fears.
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Timepoint [5]
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Baseline, after intervention completed (week 12), and at follow up time points of 3-and 6 months following the 12-week intervention.
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Secondary outcome [6]
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Change from baseline in Patient Health Questionnaire-12 (PHQ-12) (derived from PHQ-15) questionnaire
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Assessment method [6]
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PHQ-15 is a validated measure of somatization. Questions reflect the previous 4 weeks. It comprises 15 somatic symptoms with each symptom scored from 0 ("not bothered at all") to 2 ("bothered a lot"). The PHQ-15 will be administered to facilitate assessment of PHQ-12. The PHQ-12 is a commonly used modification of the PHQ-15 without three GI-related items; constipation, loose bowels, or diarrhea; nausea, gas, or indigestion. The PHQ-12 represents non-GI or extraintestinal somatic symptoms.
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Timepoint [6]
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Baseline, after intervention completed (week 12), and at follow up time points of 3-and 6 months following the 12-week intervention.
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Secondary outcome [7]
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Change from baseline in Generalized anxiety disorder (GAD-7) questionnaire
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Assessment method [7]
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GAD-7 is a 7-item questionnaire used for screening and measuring the severity of anxiety symptoms. Questions reflect the previous 14 days and responses are measured on a 4-point Likert scale; 0=not at all sure; 1=several days; 2=more than half the days; 3=nearly every day. Total GAD-7 scores range from 0-21 with higher scores indicating greater severity of symptoms.
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Timepoint [7]
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Baseline, after intervention completed (week 12), and at follow up time points of 3-and 6 months following the 12-week intervention.
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Secondary outcome [8]
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Change from baseline in Patient Health Questionnaire (PHQ-9) questionnaire
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Assessment method [8]
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The Patient Health Questionnaire (PHQ-9) is a 9-item measure of depression severity. Questions reflect the previous 14 days. Each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day) and severity score can range from 0 to 27. PHQ-9 scores of 5, 10, 15, and 20 indicate mild, moderate, moderately severe, and severe depression, respectively.
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Timepoint [8]
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Baseline, after intervention completed (week 12), and at follow up time points of 3-and 6 months following the 12-week intervention.
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Secondary outcome [9]
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Change from baseline in Gastrointestinal Specific Anxiety (GSA) measured using Visceral Sensitivity Index (VSI)
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Assessment method [9]
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The VSI is a 15-item measure of gastrointestinal-specific anxiety, scored on a Likert scale of 1 to 6 with 1=strongly agree; 2=moderately agree; 3=mildly agree; 4=mildly disagree; 5=moderately disagree and 6=strongly disagree.
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Timepoint [9]
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Baseline, after intervention completed (week 12), and at follow up time points of 3-and 6 months following the 12-week intervention.
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Secondary outcome [10]
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Change from baseline in Avoidance behavior measured using Irritable Bowel Syndrome-Behavioural Responses Questionnaire (IBS-BRQ)
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Assessment method [10]
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IBS-BRQ is a 26-item measure of avoidance behavior. The scale has 26 items, scored from 1 (never) to 7 (always), indicating how persistently the particular avoidance or toilet behavior is carried out.
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Timepoint [10]
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Baseline, after intervention completed (week 12), and at follow up time points of 3-and 6 months following the 12-week intervention.
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Secondary outcome [11]
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Change from baseline in Total FODMAP intake measured using 3-day food diary
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Assessment method [11]
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Participants will record their food intake for 3 days (including one weekend day) using paper or an app. Total FODMAP intake will be calculated g/day.
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Timepoint [11]
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Baseline, after intervention completed (week 12), and at follow up time points of 3-and 6 months following the 12-week intervention.
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Secondary outcome [12]
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Change from baseline in stool frequency and consistency using 7-day stool diary based on Bristol Stool Form Scale (BSFS)
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Assessment method [12]
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The stool diary will be completed over 7 days and is based on the Bristol Stool Form Scale (BSFS) for IBS subtyping and bowel habit assessment i.e. stool frequency and consistency. Stool consistency will be quantified according to ROME classifications.
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Timepoint [12]
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Baseline, after intervention completed (week 12), and at follow up time points of 3-and 6 months following the 12-week intervention.
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Secondary outcome [13]
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Gastrointestinal microbiome composition and function using stool sample using OMNIgene GUT
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Assessment method [13]
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Gut microbiome composition (i.e., alpha diversity, beta diversity, relative abundance) and function 16S rRNA and shotgun sequencing. Measured as exploratory mediators.
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Timepoint [13]
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Gastrointestinal microbiome composition and function will be measured 2nd weekly between baseline (prior to intervention) and after intervention completed (week 12) as exploratory mediators.
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Secondary outcome [14]
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Individual FODMAPs' intake using 3-day food diary
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Assessment method [14]
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Participants will record their food intake for 3 days (including one weekend day) using paper or an app. Individual FODMAPs' intake will be calculated g/day. Measured as exploratory mediators.
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Timepoint [14]
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Will be measured 2nd weekly between baseline (prior to intervention) and after intervention completed (week 12) as exploratory mediators.
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Secondary outcome [15]
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Gastrointestinal Symptom Rating Scale-Irritable Bowel Syndrome GSRS-IBS
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Assessment method [15]
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The GSRS-IBS is a 13-item measure of IBS symptom severity to reflect the last 7 days. The items are scored between 1 (no discomfort at all) and 7 (very severe discomfort), rendering a total score between 13 and 91. Measured as an exploratory moderator.
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Timepoint [15]
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Baseline (prior to start of intervention) as an exploratory moderator.
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Secondary outcome [16]
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IBS quality of life (IBS-QOL) questionnaire
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Assessment method [16]
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Description: I IBS-QOL is used to assess the impact on quality of life for patients with IBS and consists of 34 items scored between 1 and 5, resulting in a maximum score of 170. Measured as an exploratory moderator.
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Timepoint [16]
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Baseline (prior to start of intervention) as an exploratory moderator.
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Secondary outcome [17]
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Fear of Food Questionnaire (FFQ) questionnaire
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Assessment method [17]
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The Fear of Food Questionnaire (FFQ) is an 18-item measure of food-related fears averaged into five subscales (GI fears, food fears, food avoidance, social impairment, and distress/loss of pleasure) and a total score between 0 and 90 (each range = 0-5), with higher scores indicating greater food related fears. Measured as an exploratory moderator.
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Timepoint [17]
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Baseline (prior to start of intervention) as an exploratory moderator.
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Secondary outcome [18]
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Nine Item ARFID (Avoidant Restrictive Food Intake Disorder) Screen (NIAS) questionnaire
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Assessment method [18]
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NIAS is a 9-item measure of ARFID symptoms. The scale has 9 questions, scored from 0 (strongly disagree) to 5 (strongly agree) and summed into three subscales (fear of adverse consequences, lack of interest/appetite, and sensory sensitivity); each range = 0-15), with higher scores indicating greater severity. Measured as an exploratory moderator.
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Timepoint [18]
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Baseline (prior to start of intervention) as an exploratory moderator.
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Secondary outcome [19]
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Patient Health Questionnaire-12 (PHQ-12) (derived from PHQ-15) questionnaire
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Assessment method [19]
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PHQ-15 is a validated measure of somatization. Questions reflect the previous 4 weeks. It comprises 15 somatic symptoms with each symptom scored from 0 ("not bothered at all") to 2 ("bothered a lot"). The PHQ-15 will be administered to facilitate assessment of PHQ-12. The PHQ-12 is a commonly used modification of the PHQ-15 without three GI-related items; constipation, loose bowels, or diarrhea; nausea, gas, or indigestion. The PHQ-12 represents non-GI or extraintestinal somatic symptoms. Measured as an exploratory moderator.
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Timepoint [19]
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Baseline (prior to start of intervention) as an exploratory moderator.
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Secondary outcome [20]
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Patient Health Questionnaire (PHQ-9) questionnaire
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Assessment method [20]
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The Patient Health Questionnaire (PHQ-9) is a 9-item measure of depression severity. Questions reflect the previous 14 days. Each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day) and severity score can range from 0 to 27. PHQ-9 scores of 5, 10, 15, and 20 indicate mild, moderate, moderately severe, and severe depression, respectively. Measured as an exploratory moderator.
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Timepoint [20]
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Baseline (prior to start of intervention) as an exploratory moderator.
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Secondary outcome [21]
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Generalized anxiety disorder (GAD-7) questionnaire
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Assessment method [21]
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GAD-7 is a 7-item questionnaire used for screening and measuring the severity of anxiety symptoms. Questions reflect the previous 14 days and responses are measured on a 4-point Likert scale; 0=not at all sure; 1=several days; 2=more than half the days; 3=nearly every day. Total GAD-7 scores range from 0-21 with higher scores indicating greater severity of symptoms. Measured as an exploratory moderator.
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Timepoint [21]
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Baseline (prior to start of intervention) as an exploratory moderator.
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Secondary outcome [22]
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Gastrointestinal microbiome composition and function using stool sample using a stool sample collection kit.
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Assessment method [22]
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Gut microbiome composition (i.e., alpha diversity, beta diversity, relative abundance) and function 16S rRNA and shotgun sequencing . Measured as an exploratory moderator.
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Timepoint [22]
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Baseline (prior to start of intervention) as an exploratory moderator.
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Secondary outcome [23]
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IBS subtype using 7-day stool diary based on Bristol Stool Form Scale (BSFS).
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Assessment method [23]
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The stool diary will be completed over 7 days and is based on the Bristol Stool Form Scale (BSFS) for IBS subtyping and bowel habit assessment i.e. stool frequency and consistency. Stool consistency will be quantified according to ROME classifications. Measured as a exploratory moderator.
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Timepoint [23]
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Baseline (prior to start of intervention) as an exploratory moderator.
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Secondary outcome [24]
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Client Satisfaction Questionnaire
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Assessment method [24]
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The Client Satisfaction Questionnaire is an 8-question brief global measure of client satisfaction. The eight questions are measured on a 4-point Likert scale with questions 1, 3, 6 and 7 measured on a positive scale and questions 2, 4, 5 and 8 on a negative scale. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
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Timepoint [24]
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End of the 12-week intervention and at 3-and 6 months follow up time points after 12-week intervention..
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Secondary outcome [25]
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Proportion of participants who achieve a change from baseline in Gastrointestinal Symptom Rating Scale-Irritable Bowel Syndrome (GSRS-IBS) of >30% total score
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Assessment method [25]
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The GSRS-IBS is a 13-item measure of IBS symptom severity to reflect the last 7 days. The items are scored between 1 (no discomfort at all) and 7 (very severe discomfort), rendering a total score between 13 and 91.
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Timepoint [25]
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Baseline and after intervention completed (week 12)
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Secondary outcome [26]
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Proportion of participants who achieve a change from baseline in Irritable Bowel Syndrome - Symptom Severity Score (IBS-SSS) of =50 points total score.
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Assessment method [26]
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The IBS-SSS is a 5-item measure of the severity of IBS symptoms: frequency and severity of abdominal pain, severity of bloating, dissatisfaction with bowel habits and impact on life in general. Questions ask about IBS and gut symptoms during the past 7 days with the exception of question 4 which asks participants to enter the number of days they get pain in every 10. days. A total score ranging from 0 to 500. Mild, moderate and severe cases are indicated by scores of 75 to \<175, 175 to \<300 and \>300 respectively
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Timepoint [26]
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Baseline and after intervention completed (week 12)
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Eligibility
Key inclusion criteria
Each participant must meet all of the following criteria to be enrolled in this trial:
* Living in Australia or the United States
* Aged 18 years or older
* Body Mass Index (BMI) [Equation]18.5kg/m2 and [Equation] 34.9kg/m2
* Diagnosed with IBS by a General Practitioner, Family Physician, or Gastroenterologist, or Advanced Specialist Dietitian
* Currently fulfill Rome IV criteria for IBS
* Symptomatic at the time of recruitment (IBS-SSS > 175)
* Access to a computer and internet
* Sufficient English language and computer skills to complete a text-based online treatment
* Willing to make dietary or behavioral changes in line with the allocated treatment program
* Ability to provide informed consent
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients meeting any of the following criteria will be excluded from the trial:
* Presence or known history of other GI disease (e.g. coeliac disease, Inflammatory Bowel Disease) or history of gastrointestinal cancer
* History of major gastrointestinal surgery (not appendectomy, cholecystectomy or hemorrhoidectomy)
* Individuals who report alarm symptoms (e.g., blood in stool, recent unexplained/unintentional weight loss >5% body weight, a recent change in bowel habits if >50 years, family history of gastrointestinal cancer or gastrointestinal diseases, large volumes of diarrhea occurring at night, fever associated with gut symptoms, recurrent vomiting, persistent unexplained iron deficiency) will be excluded if appropriate medical investigations have not been conducted, unless written medical approval is provided from a general practitioner, family physical, or gastroenterologist.
* Diagnosis of major disease that could explain current gastrointestinal symptoms such as severe diabetic, cardiac, liver, neurological, neuropathy disease
* History or current diagnosis of psychotic disorder or bipolar disorder
* Current diagnosis of substance abuse disorder or major depressive disorder or active suicidal ideation
* History or current diagnosis of an eating disorder
* Current enteral/parenteral feeding or use of supplemental feeds (e.g. Ensure)
* Pregnant or lactating or planning to become pregnant during the 12-week intervention period
* Commenced or change in dose of antibiotics and medications that potentially affect the gastrointestinal transit (e.g. anti-diarrheals and laxatives) in the 3 months preceding study commencement.
* Commenced taking or changed dose of probiotics, prebiotics, fibre supplements and digestive enzymes in the 3 months preceding study commencement
* Commenced or change dose in psychotropic medication in the 3 months preceding study commencement
* Are currently undertaking behavioral therapy for IBS (including cognitive behavioral therapy, CBT), or have undertaken clinician-delivered behavioral therapy for the treatment of IBS
* Are currently undertaking or have undertaken a dietitian-prescribed and delivered restrictive diet for IBS (e.g., FODMAP diet).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/05/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/07/2027
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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University of Melbourne - Melbourne
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Recruitment postcode(s) [1]
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3010 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Melbourne
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Monash University
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This research project will assess how two treatments for irritable bowel syndrome (one dietary and one behavioral) work and for whom. This will be done by assessing moderators (what treatment works for who and in what context) and mediators (how treatment works). Investigators will also assess how the diet and behavioral treatments affect IBS symptoms during treatment. Participants will be randomized to either: i. A FODMAP diet online program that focuses on modifying the consumption of foods high or moderate in fermentable carbohydrates (FODMAPS) to manage IBS symptoms. or, ii. An Exposure-based Cognitive Behavioral Therapy (E-CBT) online program for IBS that focuses on changing symptom-related behaviors which are known to worsen IBS symptoms.
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Trial website
https://clinicaltrials.gov/study/NCT06940596
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Trial related presentations / publications
Biesiekierski JR, Manning LP, Murray HB, Vlaeyen JWS, Ljotsson B, Van Oudenhove L. Review article: exclude or expose? The paradox of conceptually opposite treatments for irritable bowel syndrome. Aliment Pharmacol Ther. 2022 Aug;56(4):592-605. doi: 10.1111/apt.17111. Epub 2022 Jul 1.
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Public notes
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Contacts
Principal investigator
Name
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Associate Professor Jessica Biesiekierski
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Address
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University of Melbourne
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Jessica Biesiekierski, A/Prof
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Address
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Country
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Phone
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+61 499 272 673
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Potential data shared includes:
* Individual participant data that underlie the results reported in the article after de-identification (text, tables, figures and appendices)
* Trial protocol
* Statistical Analysis Plan
* Participant Information Consent Form
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR), Analytic code
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When will data be available (start and end dates)?
The IPD and supporting information will be available beginning 3 months following analysis and article publication for 15 years.
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Available to whom?
The IPD and supporting information will be made available for use by future researchers from a recognized research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept University of Melbourne conditions for access.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://figshare.unimelb.edu.au/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06940596
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