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

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ClinicalTrials.gov Identifier: NCT03078634
Recruitment Status : Recruiting
First Posted : March 13, 2017
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
Chamara Basnayake, St Vincent's Hospital Melbourne

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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Functional Dyspepsia Constipation - Functional Faecal Incontinence Functional Abdominal Pain Syndrome Other Rome IV Functional Gastrointestinal Disorders Other: Multi-disciplinary clinic model Other: Standard outpatient care Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The MANTRA Study: The Multi-disciplinary Treatment of Functional Gut Disorders Study
Actual Study Start Date : March 16, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2019

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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03078634


Contacts
Contact: Chamara Basnayake, MBBS 03 9231 2211 study.mantra@svha.org.au
Contact: Michael Kamm, MBBS

Locations
Australia, Victoria
St Vincent's Hospital Recruiting
Melbourne, Victoria, Australia, 3065
Contact: Chamara Basnayake, MBBS       study.mantra@svha.org.au   
Sponsors and Collaborators
St Vincent's Hospital Melbourne
Investigators
Principal Investigator: Chamara Basnayake, MBBS Gastroenterologist / PhD candidate

Responsible Party: Chamara Basnayake, Gastroenterologist, St Vincent's Hospital Melbourne
ClinicalTrials.gov Identifier: NCT03078634     History of Changes
Other Study ID Numbers: MANTRA
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chamara Basnayake, St Vincent's Hospital Melbourne:
Irritable bowel syndrome
Constipation
Functional dyspepsia
Multi-disciplinary treatment

Additional relevant MeSH terms:
Dyspepsia
Disease
Syndrome
Constipation
Irritable Bowel Syndrome
Abdominal Pain
Digestive System Diseases
Gastrointestinal Diseases
Fecal Incontinence
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Rectal Diseases