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The University of Southampton

Research project: Management of Irritable Bowel Syndrome in primary care

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The aim of this RCT is to assess the potential efficacy of the commonly prescribed medications in UK general practice for IBS and our newly developed CBT based self-management website, Regul8. Determining the efficacy of commonly used drug treatments will help patients and doctors make informed treatment decisions regarding IBS symptoms. Furthermore, a web-based self-management CBT programme for IBS has the potential to benefit large numbers of patients with low cost to the NHS.

Irritable Bowel Syndrome (IBS) affects 10–22% of the UK population. Most patients are treated in primary care but evidence for the effectiveness of these treatments is lacking. Current GP treatment relies on a positive diagnosis, reassurance, lifestyle advice and drug therapies, but many suffer ongoing symptoms.

MIBS is feasibility factorial RCT to assess the potential efficacy of the two commonly prescribed medications in UK general practice for IBS: mebeverine (anti-spasmodic) and methylcellulose (bulking-agent) and Regul8. Regul8, is based on an existing evidence based self-management manual and was developed prior to the RCT in partnership with patients.

135 patients aged 16 to 60 years with IBS symptoms fulfilling Rome III criteria, recruited via GP practices, will be randomised to 1 of 3 levels of the drug condition: mebeverine, methylcellulose or placebo for 6 weeks and to 1 of 3 levels of the website condition, Regul8 with a nurse telephone session and email support, Regul8 with minimal email support, or no website.

The Irritable bowel symptom severity scale and IBS-QOL will be measured at baseline, 6 and 12 weeks as the primary outcomes. We will also undertake qualitative interviews at the end of treatment with a small number of the participants regarding their experience of participating in the trial and the acceptability of the trial procedures, including the medication taking.

Funding: This study was funded by a grant from the Research for Patient Benefit (RfPB) funding stream, from the National Institute of Health Research (NIHR), UK.

Trial Registration Identifier (NCT number): NCT00934973
Funders Number: PB-PG-0807-13081
EudraCT number: 2009-013426-16

The project commenced in April 2010. Results of the trial are likely to be published in 2011.

CAHP staff

  • Professor Rona Moss-Morris (PI)
  • Professor Lucy Yardley (PI)

Collaborators: Primary Medical Care and Southampton Statistical Sciences Research Institute, University of Southampton

  • Dr Hazel Everitt (Chief Investigator)
  • Professor Paul Little (PI)
  • Alice Sibelli (Trial Manager)
  • Professor Peter Smith (Statistician)

Collaborators: Southampton University Hospitals Trust (SUHT)

  • Nick Coleman, Consultant

Related research groups

Centre for Clinical and Community Applications of Health Psychology (CCCAHP)
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