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

Primary Purpose

Irritable Bowel Syndrome, Functional Dyspepsia, Constipation - Functional

Status
Unknown status
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Multi-disciplinary clinic model
Standard outpatient care
Sponsored by
St Vincent's Hospital Melbourne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Irritable Bowel Syndrome focused on measuring Irritable bowel syndrome, Constipation, Functional dyspepsia, Multi-disciplinary treatment

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • St Vincent's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Multi-Disciplinary clinic

Standard Gastrointestinal clinic

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
Proportion of subjects with constipation who score a 50% reduction in Cleveland clinic constipation scoring system
Proportion of subjects with faecal incontinence who score a 50% reduction in St Mark's Incontinence score
Proportion of subjects with functional dyspepsia who score a 50% reduction in the symptom score of the Nepean dyspepsia index
Quality of life as measured by RAND SF-36 v1
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.
Psychological wellbeing as measured by hospital anxiety and depression score (HADS)
Proportion of subjects with who answer yes to: In the past 7 days, have you had adequate relief of your gut condition? [YES/NO]
Somatisation as measured by somatic symptom scale-8 (SSS-8)
Cost to the healthcare system
$AUD per patient cost to the Australian healthcare system.
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.
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.

Full Information

First Posted
February 24, 2017
Last Updated
April 8, 2019
Sponsor
St Vincent's Hospital Melbourne
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1. Study Identification

Unique Protocol Identification Number
NCT03078634
Brief Title
The Multi-disciplinary Treatment of Functional Gut Disorders Study
Acronym
MANTRA
Official Title
The MANTRA Study: The Multi-disciplinary Treatment of Functional Gut Disorders Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 16, 2017 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
April 28, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St Vincent's Hospital Melbourne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome, Functional Dyspepsia, Constipation - Functional, Faecal Incontinence, Functional Abdominal Pain Syndrome, Other Rome IV Functional Gastrointestinal Disorders
Keywords
Irritable bowel syndrome, Constipation, Functional dyspepsia, Multi-disciplinary treatment

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
188 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multi-Disciplinary clinic
Arm Type
Active Comparator
Arm Title
Standard Gastrointestinal clinic
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Multi-disciplinary clinic model
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard outpatient care
Intervention Description
Standard care provided in outpatient clinics staffed by GI doctors only
Primary Outcome Measure Information:
Title
Proportion of subjects with global improvement in their condition.
Description
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.
Time Frame
Definition of discharge timepoint: Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first.
Secondary Outcome Measure Information:
Title
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)
Time Frame
A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Title
Proportion of subjects with constipation who score a 50% reduction in Cleveland clinic constipation scoring system
Time Frame
A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Title
Proportion of subjects with faecal incontinence who score a 50% reduction in St Mark's Incontinence score
Time Frame
A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Title
Proportion of subjects with functional dyspepsia who score a 50% reduction in the symptom score of the Nepean dyspepsia index
Time Frame
A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Title
Quality of life as measured by RAND SF-36 v1
Time Frame
A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Title
Quality of life as measured by Euro-QOL EQ-5D
Description
Scores from the EQ-5D will be compared between groups and QALY will be derived from EQ-5D.
Time Frame
A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Title
Psychological wellbeing as measured by hospital anxiety and depression score (HADS)
Time Frame
A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B)12 months after discharge.
Title
Proportion of subjects with who answer yes to: In the past 7 days, have you had adequate relief of your gut condition? [YES/NO]
Time Frame
A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Title
Somatisation as measured by somatic symptom scale-8 (SSS-8)
Time Frame
A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Title
Cost to the healthcare system
Description
$AUD per patient cost to the Australian healthcare system.
Time Frame
A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Title
Proportion of subjects with global improvement in their condition.
Description
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.
Time Frame
A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Title
Proportion of subjects with a 50% reduction in gastrointestinal symptom severity index score
Description
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.
Time Frame
A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chamara Basnayake, MBBS
Organizational Affiliation
Gastroenterologist / PhD candidate
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Vincent's Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34896645
Citation
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.
Results Reference
derived
PubMed Identifier
32679040
Citation
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.
Results Reference
derived
PubMed Identifier
31437539
Citation
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.
Results Reference
derived

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The Multi-disciplinary Treatment of Functional Gut Disorders Study

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