Clinical trial NCT03078634: The Multi-disciplinary Treatment of Functional Gut Disorders Study
Official title: The MANTRA Study: The Multi-disciplinary Treatment of Functional Gut Disorders Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Functional Dyspepsia
Constipation - Functional
Faecal Incontinence
Functional Abdominal Pain Syndrome
Other Rome IV Functional Gastrointestinal Disorders
Keywords: Irritable bowel syndrome
Constipation
Functional dyspepsia
Multi-disciplinary treatment
Lead sponsor: St Vincent's Hospital Melbourne
Sponsor class: OTHER
First posted: 2017-03-13
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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

Primary outcomes:
measure: Proportion of subjects with global improvement in their condition.
timeFrame: Definition of discharge timepoint: Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first.
Secondary outcomes:
measure: 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)
timeFrame: A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
measure: Proportion of subjects with constipation who score a 50% reduction in Cleveland clinic constipation scoring system
timeFrame: A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
measure: Proportion of subjects with faecal incontinence who score a 50% reduction in St Mark's Incontinence score
timeFrame: A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
measure: Proportion of subjects with functional dyspepsia who score a 50% reduction in the symptom score of the Nepean dyspepsia index
timeFrame: A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
measure: Quality of life as measured by RAND SF-36 v1
timeFrame: A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
measure: Quality of life as measured by Euro-QOL EQ-5D
timeFrame: A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
measure: Psychological wellbeing as measured by hospital anxiety and depression score (HADS)
timeFrame: A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B)12 months after discharge.
measure: Proportion of subjects with who answer yes to: In the past 7 days, have you had adequate relief of your gut condition? [YES/NO]
timeFrame: A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
measure: Somatisation as measured by somatic symptom scale-8 (SSS-8)
timeFrame: A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
measure: Cost to the healthcare system
timeFrame: A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
measure: Proportion of subjects with global improvement in their condition.
timeFrame: A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
measure: Proportion of subjects with a 50% reduction in gastrointestinal symptom severity index score
timeFrame: A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: St Vincent's Hospital
state: Victoria
Study officials:
affiliation: Gastroenterologist / PhD candidate
name: Chamara Basnayake, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.