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Trial registered on ANZCTR


Registration number
ACTRN12625000399493p
Ethics application status
Submitted, not yet approved
Date submitted
4/04/2025
Date registered
2/05/2025
Date last updated
2/05/2025
Date data sharing statement initially provided
2/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating a Bile Acid Binder to Help Adults with Chronic Diarrhoea
Scientific title
Bile acid sequestrant tolerability and symptom change in adults with chronic diarrhoea
Secondary ID [1] 314120 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bile Acid Malabsorption 336923 0
Chronic Diarrhea 337323 0
Condition category
Condition code
Oral and Gastrointestinal 333392 333392 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants with functional chronic diarrhoea will receive 14 days of cholestyramine, a bile acid sequestrant in powder form, to drink dissolved in liquid according to manufacturer's guidelines: "QUESTRAN LITE should be taken mixed with water, juice or highly fluid foods. When mixing individual sachets for immediate use, place the contents of a 4g sachet of QUESTRAN LITE on the surface of 100-150mL water or fruit juice (200-300mL for an 8g sachet of QUESTRAN LITE). Mix immediately by stirring vigorously or preferably by shaking in a Questran Lite shaker. Continue stirring or shaking until mixture is even. After dosing, rinse the container to ensure full dose. Alternatively, QUESTRAN LITE may be mixed with highly fluid soups, pulpy fruits with a high moisture content (e.g., apple puree or crushed pineapple), or if care is taken to avoid excessive foaming, a carbonated beverage.. Specifically, 4g of cholestyramine is equivalent to 4.7g Questran Lite (prescription brand name) per day in the evening or morning, increasing it to up to 12g cholestyramine /14.1g of Questran Lite over 14 days. Begin with 4g cholestyramine (4.7 QUESTRAN LITE) in the morning or evening, increasing to the required maintenance dose over 2 to 4 weeks."
There is no strict protocol since the dose has to be adjusted individually, with input from the medical officer, depending on tolerability.
Adherence is not monitored, as it is a prescription drug, and there are no lab tests available for monitoring.
Intervention code [1] 330700 0
Diagnosis / Prognosis
Intervention code [2] 330850 0
Treatment: Other
Comparator / control treatment
No control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340965 0
Number of participants with a significant change in bowel habits (complete spontaneous bowel movements per week) after taking bile acid sequestrants (responders)
Timepoint [1] 340965 0
Baseline (screening) and after 14 days of taking the intervention
Secondary outcome [1] 445627 0
Changes in bowel movements are measured as complete spontaneous bowel movements (CSBM) per week. A CSBM is a bowel movement that occurs by itself without manual maneuver or laxative, and feels complete to the participant.
Timepoint [1] 445627 0
From baseline until the end of 14 days of intervention, e.g., up to 21 days.
Secondary outcome [2] 445629 0
Selectivity and specificity of bile acid plasma biomarkers FGF19 and C4. This will be assessed as a composite secondary outcome.
Timepoint [2] 445629 0
Baseline and after 14 days of intervention
Secondary outcome [3] 445630 0
The occurrence of known side effects such as constipation, nausea, and flatulence.
Timepoint [3] 445630 0
Three months after the last sample is collected

Eligibility
Key inclusion criteria
BMI 17-37
Participants with a known diagnosis of IBS-D or Functional Diarrhoea (FD)
Participants with a suspected diagnosis of IBS-D or FD, or chronic diarrhoea symptoms according to RomeIV criteria
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current treatment with bile acid sequestrants
Inability to give informed consent
Known significant gastrointestinal disorder such as colorectal cancer, diverticulitis
Coeliac disease
Pregnancy
Contraindications for bile-acid sequestrants
Laxative use
Those with symptoms atypical for functional gastrointestinal disease or where there is a high index of suspicion for other diagnoses (eg colorectal cancer, ischaemic colitis, infective colitis).
Those with an acute health problem as determined through the biochemical blood panel

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
All collected data will be analysed using an intention-to-treat (ITT) approach, with the guidance of the biostatistician and Co-PI Chris Frampton. Univariate and covariate analyses will be conducted to assess and compare changes in patient-reported outcomes and blood biomarkers. Categorical data will be evaluated using Chi-square tests and logistic regression. Descriptive statistics, including means, medians, standard deviations, ranges, frequencies, and percentages, will be used to summarize presenting features and outcome measures, based on the type of variable. All statistical analyses will be performed with SPSS version 28, and a two-tailed p-value of <0.05 will be considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2025
Actual
Date of last participant enrolment
Anticipated
1/12/2026
Actual
Date of last data collection
Anticipated
30/12/2026
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 26947 0
New Zealand
State/province [1] 26947 0
Canterbury

Funding & Sponsors
Funding source category [1] 318629 0
Charities/Societies/Foundations
Name [1] 318629 0
New Zealand Society of Gastroenterology
Country [1] 318629 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 321065 0
None
Name [1] 321065 0
Address [1] 321065 0
Country [1] 321065 0
Other collaborator category [1] 283466 0
Hospital
Name [1] 283466 0
Christchurch Public Hospital/ Te Whatu Ora
Address [1] 283466 0
Country [1] 283466 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317233 0
Northern A Health and Disability Ethics Committee 
Ethics committee address [1] 317233 0
Ethics committee country [1] 317233 0
New Zealand
Date submitted for ethics approval [1] 317233 0
17/04/2025
Approval date [1] 317233 0
Ethics approval number [1] 317233 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140422 0
Dr Simone Bayer
Address 140422 0
Department of Medicine, University of Otago Christchurch, Riccarton Ave 2, 8011 Christchurch
Country 140422 0
New Zealand
Phone 140422 0
+64 021 279 1519
Fax 140422 0
Email 140422 0
[email protected]
Contact person for public queries
Name 140423 0
Simone Bayer
Address 140423 0
Department of Medicine, University of Otago Christchurch, Riccarton Ave 2, 8011 Christchurch
Country 140423 0
New Zealand
Phone 140423 0
+64 021 279 1519
Fax 140423 0
Email 140423 0
[email protected]
Contact person for scientific queries
Name 140424 0
Simone Bayer
Address 140424 0
Department of Medicine, University of Otago Christchurch, Riccarton Ave 2, 8011 Christchurch
Country 140424 0
New Zealand
Phone 140424 0
+64 021 279 1519
Fax 140424 0
Email 140424 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24599Study protocol    BAM_Research-Protocol V3.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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