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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)

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)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-013426-16-GB
Enrollment
150
Registered
2009-10-23
Start date
2009-11-16
Completion date
Unknown
Last updated
2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Interventions

Trade Name: celevac Product Name: methylcellulose - Celevac Pharmaceutical Form: Tablet INN or Proposed INN: methylcellulose - Celevac C

Sponsors

University of Southampton
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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.—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026