The Multi-disciplinary Treatment of Functional Gut Disorders Study

Study Overview
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Brief Summary
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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.

Official Title
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The MANTRA Study: The Multi-disciplinary Treatment of Functional Gut Disorders Study

Conditions
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Irritable Bowel Syndrome, Functional Dyspepsia, Constipation - Functional, Faecal Incontinence, Functional Abdominal Pain Syndrome, Other Rome IV Functional Gastrointestinal Disorders

Intervention / Treatment
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* Other: Multi-disciplinary clinic model
* Other: Standard outpatient care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Functional gastrointestinal disorder as defined by Rome IV 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Multi-Disciplinary clinic<br> | Other: Multi-disciplinary clinic model<br>* 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.<br>|
| Placebo Comparator: Standard Gastrointestinal clinic<br> | Other: Standard outpatient care<br>* Standard care provided in outpatient clinics staffed by GI doctors only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Definition of discharge timepoint: Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge. | 
| Proportion of subjects with constipation who score a 50% reduction in Cleveland clinic constipation scoring system |  | A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge. | 
| Proportion of subjects with faecal incontinence who score a 50% reduction in St Mark's Incontinence score |  | A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge. | 
| Proportion of subjects with functional dyspepsia who score a 50% reduction in the symptom score of the Nepean dyspepsia index |  | A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge. | 
| Quality of life as measured by RAND SF-36 v1 |  | A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge. | 
| 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. | A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge. | 
| Psychological wellbeing as measured by hospital anxiety and depression score (HADS) |  | A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B)12 months after discharge. | 
| Proportion of subjects with who answer yes to: In the past 7 days, have you had adequate relief of your gut condition? [YES/NO] |  | A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge. | 
| Somatisation as measured by somatic symptom scale-8 (SSS-8) |  | A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge. | 
| Cost to the healthcare system | $AUD per patient cost to the Australian healthcare system. | A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge. | 
| 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. | A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge. | 
| 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. | A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Irritable bowel syndrome, Constipation, Functional dyspepsia, Multi-disciplinary treatment