The Multi-disciplinary Treatment of Functional Gut Disorders Study

Not Applicable

Completed

• Conditions: Constipation - Functional; Faecal Incontinence; Other Rome IV Functional Gastrointestinal Disorders; Irritable Bowel Syndrome; Functional Dyspepsia; Functional Abdominal Pain Syndrome
• Interventions: Other: Multi-disciplinary clinic model; Other: Standard outpatient care

• Registration Number: NCT03078634
• Lead Sponsor: St Vincent's Hospital Melbourne

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-24
• Study First Submitted QC: 2017-03-07
• Study First Posted: 2017-03-13
• Study Start: 2017-03-16
• Primary Completion: 2019-02-28
• Study Completion: 2020-04-28
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multi-Disciplinary clinic	Multi-disciplinary clinic model	-
Standard Gastrointestinal clinic	Standard outpatient care	-

Primary Outcome Measures

Name	Time	Method
Proportion of subjects with global improvement in their condition.	Definition of discharge timepoint: Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first.	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.

Secondary Outcome Measures

Name	Time	Method
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 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.
Quality of life as measured by Euro-QOL EQ-5D	A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.	Scores from the EQ-5D will be compared between groups and QALY will be derived from EQ-5D.
Proportion of subjects with global improvement in their condition.	A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.	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.
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.
Cost to the healthcare system	A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.	$AUD per patient cost to the Australian healthcare system.
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.
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.
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.
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.
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.
Proportion of subjects with a 50% reduction in gastrointestinal symptom severity index score	A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.	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.

Trial Locations

Locations (1)

St Vincent's Hospital; 🇦🇺 Melbourne, Victoria, Australia