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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03078634
Other study ID # MANTRA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 16, 2017
Est. completion date April 28, 2020

Study information

Verified date November 2023
Source St Vincent's Hospital Melbourne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 188
Est. completion date April 28, 2020
Est. primary completion date February 28, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Intervention

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.
Standard outpatient care
Standard care provided in outpatient clinics staffed by GI doctors only

Locations

Country Name City State
Australia St Vincent's Hospital Melbourne Victoria

Sponsors (1)

Lead Sponsor Collaborator
St Vincent's Hospital Melbourne

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of subjects with global improvement in their condition. 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. Definition of discharge timepoint: Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first.
Secondary 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) A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Secondary Proportion of subjects with constipation who score a 50% reduction in Cleveland clinic constipation scoring system A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Secondary Proportion of subjects with faecal incontinence who score a 50% reduction in St Mark's Incontinence score A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Secondary Proportion of subjects with functional dyspepsia who score a 50% reduction in the symptom score of the Nepean dyspepsia index A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Secondary Quality of life as measured by RAND SF-36 v1 A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Secondary Quality of life as measured by Euro-QOL EQ-5D Scores from the EQ-5D will be compared between groups and QALY will be derived from EQ-5D. A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Secondary Psychological wellbeing as measured by hospital anxiety and depression score (HADS) A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B)12 months after discharge.
Secondary Proportion of subjects with who answer yes to: In the past 7 days, have you had adequate relief of your gut condition? [YES/NO] A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Secondary Somatisation as measured by somatic symptom scale-8 (SSS-8) A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Secondary Cost to the healthcare system $AUD per patient cost to the Australian healthcare system. A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Secondary Proportion of subjects with global improvement in their condition. 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. A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
Secondary Proportion of subjects with a 50% reduction in gastrointestinal symptom severity index score 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. A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.
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