Management of Irritable Bowel Syndrome in Primary Care: Feasibility randomised controlled trial of mebeverine, methylcellulose, placebo and a patient self-management cognitive behavioural therapy website. (MIBS Trial) - Management of Irritable Bowel Syndrome in Primary Care: RCT (MIBS)

Phase 1

• Conditions: Irritable Bowel Syndrome

• Registration Number: EUCTR2009-013426-16-GB
• Lead Sponsor: niversity of Southampton

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-23
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

Patients aged 16 to 60 yrs with symptoms of irritable bowel syndrome that fulfil the Rome III criteria.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Atypical symptoms – (unexplained weight loss, rectal bleeding), diagnosis of inflammatory bowel disease, coeliac disease, peptic ulcer disease, porphyria, pregnant or breast feeding, currently taking or allergy to mebeverine or methylcellulose. If patients are already taking mebeverine or methlycellulose but are keen to enter the trial they will be able to do so if they fulfil the inclusion criteria, do not meet any of the other exclusion criteria and they undertake a 4 week mebeverine and methylcellulose free wash out period before entering the trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To pilot an RCT to assess the effectiveness of the prescribed medications in UK general practice for IBS: mebeverine (an anti-spasmodic) and methylcellulose (bulking-agent) against placebo and assess a newly developed CBT-based patient self-management website ;Secondary Objective: To assess the level of support needed for patients using the website (i.e. initial 30 minute telephone session with a nurse and email reminders or minimal contact (website access and technical support only)).;Primary end point(s): IBS SSS score and IBS-QOL at baseline, six and twelve weeks.