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Management of Irritable Bowel Syndrome in Primary Care (MIBS Trial)

NCT00934973 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2021-04-30

No results posted yet for this study

Summary

Aims:

1. To pilot an randomized, controlled trial (RCT) to assess the effectiveness of the commonly prescribed medications in UK general practice for IBS: mebeverine (anti-spasmodic) and methylcellulose (bulking-agent) and of the patient CBT based self-management website.
2. To assess the level of support needed for patients using the patient CBT based self-management website for IBS (i.e., initial 30 minute telephone support session with a nurse and email support or not).

Conditions

  • Irritable Bowel Syndrome

Interventions

DRUG

mebeverine

overencapsulated mebeverine 135 mg tds for 6 weeks

DRUG

methylcellulose

overencapsulated methylcellulose 3 tablets bd for 6 weeks

DRUG

placebo

overencapsulated placebo tablets 1 tds for 6 weeks

BEHAVIORAL

CBT website with support

cognitive behavioral therapy with nurse telephone session and email support

BEHAVIORAL

No website

No CBT website

BEHAVIORAL

CBT website with minimal support

Sponsors & Collaborators

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • Hazel Everitt

    lead OTHER

Principal Investigators

  • Hazel A Everitt, MBChB · University of Southampton

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
16 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-09-30
Completion
2011-10-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00934973 on ClinicalTrials.gov