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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03078634
Recruitment Status : Unknown
Verified April 2019 by Chamara Basnayake, St Vincent's Hospital Melbourne.
Recruitment status was:  Active, not recruiting
First Posted : March 13, 2017
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Chamara Basnayake, St Vincent's Hospital Melbourne

Tracking Information
First Submitted Date  ICMJE February 24, 2017
First Posted Date  ICMJE March 13, 2017
Last Update Posted Date April 10, 2019
Actual Study Start Date  ICMJE March 16, 2017
Actual Primary Completion Date February 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2017)
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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.
  • 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. ]
  • 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. ]
  • 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. ]
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Multi-disciplinary Treatment of Functional Gut Disorders Study
Official Title  ICMJE The MANTRA Study: The Multi-disciplinary Treatment of Functional Gut Disorders Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Irritable Bowel Syndrome
  • Functional Dyspepsia
  • Constipation - Functional
  • Faecal Incontinence
  • Functional Abdominal Pain Syndrome
  • Other Rome IV Functional Gastrointestinal Disorders
Intervention  ICMJE
  • 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.
  • Other: Standard outpatient care
    Standard care provided in outpatient clinics staffed by GI doctors only
Study Arms  ICMJE
  • Active Comparator: Multi-Disciplinary clinic
    Intervention: Other: Multi-disciplinary clinic model
  • Placebo Comparator: Standard Gastrointestinal clinic
    Intervention: Other: Standard outpatient care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: March 19, 2018)
188
Original Estimated Enrollment  ICMJE
 (submitted: March 7, 2017)
234
Estimated Study Completion Date  ICMJE April 28, 2020
Actual Primary Completion Date February 28, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03078634
Other Study ID Numbers  ICMJE MANTRA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Chamara Basnayake, St Vincent's Hospital Melbourne
Study Sponsor  ICMJE St Vincent's Hospital Melbourne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chamara Basnayake, MBBS Gastroenterologist / PhD candidate
PRS Account St Vincent's Hospital Melbourne
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP