Management of Irritable Bowel Syndrome in Primary Care (MIBS Trial)
NCT ID: NCT00934973
Last Updated: 2021-04-30
Study Results
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Basic Information
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COMPLETED
PHASE4
135 participants
INTERVENTIONAL
2010-04-30
2011-10-31
Brief Summary
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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).
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Detailed Description
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Irritable bowel syndrome (IBS) affects 10-22% of the United Kingdom (UK) population, with National Health Service (NHS) costs over £200 million a year. Abdominal pain, bloating and altered bowel habit affect quality of life, social functioning and time off work. Current general practitioner (GP) treatment relies on a positive diagnosis, reassurance, lifestyle advice and drug therapies, but many suffer ongoing symptoms.
A recent Cochrane review highlighted the lack of research evidence for IBS drugs. Neither GPs, nor patients have good evidence to inform prescribing decisions. However, IBS drugs are widely used: NHS costs 2005 of nearly £10 million for mebeverine and over £8 million for fiber-based bulking agents.
Cognitive behavioral therapy (CBT) and self-management can be helpful, but poor availability in the NHS restricts its use. Development of web-based CBT could increase access without increased costs.
Plan of Investigation:
135 patients aged 16-60 years with IBS symptoms fulfilling the Rome III criteria, recruited via GP practices, will be randomised to: mebeverine, methylcellulose or placebo for 6 weeks and to the CBT based website with a nurse telephone session and email support, website with minimal support, or no website, thus creating 9 groups.
Outcomes: Irritable bowel symptom severity scale and IBS-QOL will be measured at baseline, 6 and 12 weeks. An intention to treat analysis will be undertaken by analysis of covariance (ANCOVA) for a factorial trial.
Potential Impact:
Development of a web-based self-management CBT program for IBS developed in partnership with patients has the potential to benefit large numbers of patients with low cost to the NHS. CBT has been shown to be of benefit for IBS but it's availability is limited due to the high cost and therapist time required for face-to-face CBT. A website can be accessed at a time and place convenient to the patient and the CBT program undertaken at a pace determined by patient needs. The website could be used as a long term support for self-management.
Determining the effectiveness of commonly used drug treatments will help patients and doctors in making informed treatment decisions regarding the drug management of IBS symptoms, enabling better targeting of treatment to those who may benefit.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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mebeverine + no website
Mebeverine 135mg tds for 6 weeks
mebeverine
overencapsulated mebeverine 135 mg tds for 6 weeks
No website
No CBT website
methylcellulose + no website
methylcellulose 3 tablets twice a day for 6 weeks
methylcellulose
overencapsulated methylcellulose 3 tablets bd for 6 weeks
No website
No CBT website
placebo + no website
placebo tablets
placebo
overencapsulated placebo tablets 1 tds for 6 weeks
No website
No CBT website
mebeverine + CBT website minimal support
mebeverine 135mg tds and access to website
mebeverine
overencapsulated mebeverine 135 mg tds for 6 weeks
CBT website with minimal support
methylcellulose + CBT website
methylellulose 3 tablets twice a day and access to website
methylcellulose
overencapsulated methylcellulose 3 tablets bd for 6 weeks
CBT website with minimal support
placebo + CBT website minimal support
placebo tablets and access to website
placebo
overencapsulated placebo tablets 1 tds for 6 weeks
CBT website with minimal support
mebeverine + CBT website with support
mebeverine 135mg tds and access to website with nurse support session
mebeverine
overencapsulated mebeverine 135 mg tds for 6 weeks
CBT website with support
cognitive behavioral therapy with nurse telephone session and email support
methylcellulose + CBT website support
methylcellulose 3 tablets twice a day and access to website with nurse support
methylcellulose
overencapsulated methylcellulose 3 tablets bd for 6 weeks
CBT website with support
cognitive behavioral therapy with nurse telephone session and email support
placebo + CBT website with support
placebo tablets and access to website with nurse support
placebo
overencapsulated placebo tablets 1 tds for 6 weeks
CBT website with support
cognitive behavioral therapy with nurse telephone session and email support
Interventions
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mebeverine
overencapsulated mebeverine 135 mg tds for 6 weeks
methylcellulose
overencapsulated methylcellulose 3 tablets bd for 6 weeks
placebo
overencapsulated placebo tablets 1 tds for 6 weeks
CBT website with support
cognitive behavioral therapy with nurse telephone session and email support
No website
No CBT website
CBT website with minimal support
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Diagnosis of inflammatory bowel disease, coeliac disease or peptic ulcer disease
* Pregnant or breast feeding
* Currently taking or allergy to mebeverine or methylcellulose
16 Years
60 Years
ALL
Yes
Sponsors
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National Institute for Health Research, United Kingdom
OTHER_GOV
Hazel Everitt
OTHER
Responsible Party
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Hazel Everitt
Principal Investigator
Principal Investigators
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Hazel A Everitt, MBChB
Role: PRINCIPAL_INVESTIGATOR
University of Southampton
Locations
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University of Southampton
Southampton, Hampshire, United Kingdom
Countries
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References
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Everitt H, Moss-Morris R, Sibelli A, Tapp L, Coleman N, Yardley L, Smith P, Little P. Management of irritable bowel syndrome in primary care: the results of an exploratory randomised controlled trial of mebeverine, methylcellulose, placebo and a self-management website. BMC Gastroenterol. 2013 Apr 21;13:68. doi: 10.1186/1471-230X-13-68.
Everitt HA, Moss-Morris RE, Sibelli A, Tapp L, Coleman NS, Yardley L, Smith PW, Little PS. 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). BMC Gastroenterol. 2010 Nov 18;10:136. doi: 10.1186/1471-230X-10-136.
Other Identifiers
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2009-013426-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
5953
Identifier Type: -
Identifier Source: org_study_id
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