The Multi-disciplinary Treatment of Functional Gut Disorders Study

Irritable Bowel Syndrome Clinical Trial

— MANTRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03078634
• Other study ID #: MANTRA
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Abdominal Pain
• Constipation
• Constipation - Functional
• Digestive System Diseases
• Dyspepsia
• Faecal Incontinence
• Fecal Incontinence
• Functional Abdominal Pain Syndrome
• Functional Dyspepsia
• Gastrointestinal Diseases
• Irritable Bowel Syndrome
• Other Rome IV Functional Gastrointestinal Disorders
• Syndrome

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.