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COMPLETEDNA

The Multi-disciplinary Treatment of Functional Gut Disorders Study

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

NCT03078634•St Vincent's Hospital Melbourne

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Yes

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
+1 more criteria

Locations (1)

St Vincent's Hospital

Melbourne, Victoria, Australia

Key Dates

Start Date

March 16, 2017

Primary Completion Date

February 28, 2019

Completion Date

April 28, 2020

Last Updated

November 29, 2023

Enrollment

188

ACTUAL participants

Conditions

Irritable Bowel SyndromeFunctional DyspepsiaConstipation - FunctionalFaecal IncontinenceFunctional Abdominal Pain SyndromeOther Rome IV Functional Gastrointestinal Disorders

Interventions

Multi-disciplinary clinic model

OTHER

Standard outpatient care

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 29, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Multi-disciplinary Treatment of Functional Gut Disorders Study

Inclusion Criteria

Exclusion Criteria

Safety and Efficacy of Lyophilized Faecal Microbiota Transplantation Via Capsules in Treatment of Irritable Bowel Syndrome

Efficacy and Safety Evaluation of Fecal Microbiota Transplantation in Irritable Bowel Syndrome

ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects

Well-being in IBS: Strengths and Happiness (WISH) 2.0

Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia

Reliability of a Food Frequency Questionnaire in the Assessment of Dietary Intake Including FODMAPs in Different Populations, and Relationship With IBS Symptoms and the Degree of Self-assessed Physical Activity