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Completed

NCT Number: NCT03078634

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.

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Key information

Conditions

Irritable Bowel Syndrome Behavior Behavioral Symptoms Colonic Diseases Colonic Diseases, Functional Constipation Constipation - Functional Digestive System Diseases Elimination Disorders Encopresis Faecal Incontinence Functional Abdominal Pain Syndrome Functional Dyspepsia Gastrointestinal Diseases Intestinal Diseases Mental Disorders Other Rome IV Functional Gastrointestinal Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Vincent's Hospital

Melbourne, Victoria, 3065, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multi-disciplinary clinic model

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 outpatient care

Other

Standard care provided in outpatient clinics staffed by GI doctors only

Primary outcomes

  1. Proportion of subjects with global improvement in their condition.

    Time frame: 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Quality of life as measured by Euro-QOL 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.

    Scores from the EQ-5D will be compared between groups and QALY will be derived from EQ-5D.

  7. 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.

  8. 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.

  9. 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.

  10. Cost to the 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.

    $AUD per patient cost to the Australian healthcare system.

  11. Proportion of subjects with global improvement in their condition.

    Time frame: 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.

  12. Proportion of subjects with a 50% reduction in gastrointestinal symptom severity index 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.

    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.

Sponsors and collaborators

Lead sponsor

St Vincent's Hospital Melbourne

Other

Registry information

Official study title

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

Acronym: MANTRA

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Mar 13, 2017
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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