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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03078634




Registration number
NCT03078634
Ethics application status
Date submitted
24/02/2017
Date registered
13/03/2017
Date last updated
10/04/2019

Titles & IDs
Public title
The Multi-disciplinary Treatment of Functional Gut Disorders Study
Scientific title
The MANTRA Study: The Multi-disciplinary Treatment of Functional Gut Disorders Study
Secondary ID [1] 0 0
MANTRA
Universal Trial Number (UTN)
Trial acronym
MANTRA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Irritable Bowel Syndrome 0 0
Functional Dyspepsia 0 0
Constipation - Functional 0 0
Faecal Incontinence 0 0
Functional Abdominal Pain Syndrome 0 0
Other Rome IV Functional Gastrointestinal Disorders 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Multi-disciplinary clinic model
Other interventions - Standard outpatient care

Active Comparator: Multi-Disciplinary clinic -

Placebo Comparator: Standard Gastrointestinal clinic -


Other interventions: Multi-disciplinary clinic model
Clinic model incorporating multiple disciplines for the treatment of functional gut disorders. Disciplines include: gastroenterologists, psychiatrists, psychologists, hypnotherapists, behavioural therapists and dieticians. End of clinic case conference involving clinical disciplines will also occur to coordinate care.

Other interventions: Standard outpatient care
Standard care provided in outpatient clinics staffed by GI doctors only

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of subjects with global improvement in their condition. - Global improvement in their condition is defined as a response of either "slightly better" or "much better" to the question: "Compared with before I was first seen in clinic, I feel my gut condition is now:". The question is marked on a 5-point likert scale: Much worse, slightly worse, same, slightly better, much better.
Timepoint [1] 0 0
Definition of discharge timepoint: Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first.
Secondary outcome [1] 0 0
Proportion of subjects, with Irritable bowel syndrome or centrally mediated abdominal pain syndrome, with a 50% reduction in Irritable bowel syndrome severity scoring system (IBS-SSS)
Timepoint [1] 0 0
A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Secondary outcome [2] 0 0
Proportion of subjects with constipation who score a 50% reduction in Cleveland clinic constipation scoring system
Timepoint [2] 0 0
A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Secondary outcome [3] 0 0
Proportion of subjects with faecal incontinence who score a 50% reduction in St Mark's Incontinence score
Timepoint [3] 0 0
A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Secondary outcome [4] 0 0
Proportion of subjects with functional dyspepsia who score a 50% reduction in the symptom score of the Nepean dyspepsia index
Timepoint [4] 0 0
A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Secondary outcome [5] 0 0
Quality of life as measured by RAND SF-36 v1
Timepoint [5] 0 0
A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Secondary outcome [6] 0 0
Quality of life as measured by Euro-QOL EQ-5D - Scores from the EQ-5D will be compared between groups and QALY will be derived from EQ-5D.
Timepoint [6] 0 0
A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Secondary outcome [7] 0 0
Psychological wellbeing as measured by hospital anxiety and depression score (HADS)
Timepoint [7] 0 0
A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B)12 months after discharge.
Secondary outcome [8] 0 0
Proportion of subjects with who answer yes to: In the past 7 days, have you had adequate relief of your gut condition? [YES/NO]
Timepoint [8] 0 0
A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Secondary outcome [9] 0 0
Somatisation as measured by somatic symptom scale-8 (SSS-8)
Timepoint [9] 0 0
A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Secondary outcome [10] 0 0
Cost to the healthcare system - $AUD per patient cost to the Australian healthcare system.
Timepoint [10] 0 0
A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Secondary outcome [11] 0 0
Proportion of subjects with global improvement in their condition. - Global improvement in their condition is defined as a response of either "slightly better" or "much better" to the question: "Compared with before I was first seen in clinic, I feel my gut condition is now:". The question is marked on a 5-point likert scale: Much worse, slightly worse, same, slightly better, much better.
Timepoint [11] 0 0
A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Secondary outcome [12] 0 0
Proportion of subjects with a 50% reduction in gastrointestinal symptom severity index score - Patients will complete a GISSI (Gastrointestinal symptom severity index) questionnaire at time of "discharge from clinic" and 12 months after "discharge from clinic". The score used will be specific to their symptom cluster.
Timepoint [12] 0 0
A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.

Eligibility
Key inclusion criteria
- Functional gastrointestinal disorder as defined by Rome IV
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Diagnosed or suspicion of organic gastrointestinal disorder (ie Coeliac, IBD)

- Age <18 or >80

- Non-English speaking

- Patient's from outside of metropolitan Melbourne who cannot attend clinic visits

- Prominent eating disorder

- Chronic opioid dependence

- Medications which can explain functional gut symptoms

- Surgery of GI tract that can explain functional gut symptoms

- Major, non-GI, organ dysfunction

- Pregnancy

- Major Psychiatric disorder

Study design
Purpose of the study
Health Services Research
Allocation to intervention
Randomised controlled 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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3065 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
St Vincent's Hospital Melbourne
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Randomised controlled trial comparing standard outpatient clinic treatment with
multi-disciplinary clinic treatment for functional gastrointestinal disorders. Patients will
be followed up to end of clinic treatment and 12 months beyond the end of treatment.
Symptoms, quality of life, costs to the healthcare system and psychological outcomes will be
assessed.
Trial website
https://clinicaltrials.gov/show/NCT03078634
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Chamara Basnayake, MBBS
Address 0 0
Gastroenterologist / PhD candidate
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03078634