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The Multi-disciplinary Treatment of Functional Gut Disorders Study

NCT ID: NCT03078634

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-16

Study Completion Date

2020-04-28

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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Multi-Disciplinary clinic

Group Type ACTIVE_COMPARATOR

Multi-disciplinary clinic model

Intervention Type OTHER

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.

Standard Gastrointestinal clinic

Group Type PLACEBO_COMPARATOR

Standard outpatient care

Intervention Type OTHER

Standard care provided in outpatient clinics staffed by GI doctors only

Interventions

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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.

Intervention Type OTHER

Standard outpatient care

Standard care provided in outpatient clinics staffed by GI doctors only

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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St Vincent's Hospital Melbourne

OTHER

Sponsor Role lead

Responsible Party

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Chamara Basnayake

Gastroenterologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chamara Basnayake, MBBS

Role: PRINCIPAL_INVESTIGATOR

Gastroenterologist / PhD candidate

Locations

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St Vincent's Hospital

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

References

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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.

Reference Type DERIVED
PMID: 34896645 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32679040 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31437539 (View on PubMed)

Other Identifiers

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MANTRA

Identifier Type: -

Identifier Source: org_study_id