The Multi-disciplinary Treatment of Functional Gut Disorders Study (MANTRA)

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 188
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3065
      • St Vincent's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Multi-Disciplinary clinic	Other: 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.
Placebo Comparator: Standard Gastrointestinal clinic	Other: Standard outpatient care; Standard care provided in outpatient clinics staffed by GI doctors only

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: St Vincent's Hospital Melbourne
• Investigators: Principal Investigator: Chamara Basnayake, MBBS, Gastroenterologist / PhD candidate

Publications and helpful links

General Publications

• Basnayake C, Kamm MA, Stanley A, Wilson-O'Brien A, Burrell K, Lees-Trinca I, Khera A, Kantidakis J, Wong O, Fox K, Talley NJ, Liew D, Salzberg MR, Thompson AJ. Long-Term Outcome of Multidisciplinary Versus Standard Gastroenterologist Care for Functional Gastrointestinal Disorders: A Randomized Trial. Clin Gastroenterol Hepatol. 2022 Sep;20(9):2102-2111.e9. doi: 10.1016/j.cgh.2021.12.005. Epub 2021 Dec 9.
• Basnayake C, Kamm MA, Stanley A, Wilson-O'Brien A, Burrell K, Lees-Trinca I, Khera A, Kantidakis J, Wong O, Fox K, Talley NJ, Liew D, Salzberg MR, Thompson AJ. Standard gastroenterologist versus multidisciplinary treatment for functional gastrointestinal disorders (MANTRA): an open-label, single-centre, randomised controlled trial. Lancet Gastroenterol Hepatol. 2020 Oct;5(10):890-899. doi: 10.1016/S2468-1253(20)30215-6. Epub 2020 Jul 14.
• Basnayake C, Kamm MA, Salzberg M, Khera A, Liew D, Burrell K, Wilson-O'Brien A, Stanley A, Talley NJ, Thompson AJ. Defining Optimal Care for Functional Gut Disorders - Multi-Disciplinary Versus Standard Care: A Randomized Controlled Trial Protocol. Contemp Clin Trials. 2019 Sep;84:105828. doi: 10.1016/j.cct.2019.105828. Epub 2019 Aug 19.

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2017
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): April 28, 2020

Study Registration Dates

• First Submitted: February 24, 2017
• First Submitted That Met QC Criteria: March 7, 2017
• First Posted (Actual): March 13, 2017

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Constipation; Irritable bowel syndrome; Functional dyspepsia; Multi-disciplinary treatment
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease; Signs and Symptoms, Digestive; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Syndrome; Dyspepsia; Irritable Bowel Syndrome; Abdominal Pain; Gastrointestinal Diseases; Digestive System Diseases; Constipation; Fecal Incontinence
• Other Study ID Numbers: MANTRA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No