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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00934973
Recruitment Status : Completed
First Posted : July 8, 2009
Last Update Posted : April 30, 2021
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Hazel Everitt, University of Southampton

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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).

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Drug: mebeverine Drug: methylcellulose Drug: placebo Behavioral: CBT website with support Behavioral: No website Behavioral: CBT website with minimal support Phase 4

Detailed Description:

Background:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : April 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: mebeverine + no website
Mebeverine 135mg tds for 6 weeks
 Drug: mebeverine
overencapsulated mebeverine 135 mg tds for 6 weeks

Behavioral: No website
No CBT website
Active Comparator: methylcellulose + no website
methylcellulose 3 tablets twice a day for 6 weeks
 Drug: methylcellulose
overencapsulated methylcellulose 3 tablets bd for 6 weeks

Behavioral: No website
No CBT website
Placebo Comparator: placebo + no website
placebo tablets
 Drug: placebo
overencapsulated placebo tablets 1 tds for 6 weeks

Behavioral: No website
No CBT website
Active Comparator: mebeverine + CBT website minimal support
mebeverine 135mg tds and access to website
 Drug: mebeverine
overencapsulated mebeverine 135 mg tds for 6 weeks

Behavioral: CBT website with minimal support
Active Comparator: methylcellulose + CBT website
methylellulose 3 tablets twice a day and access to website
 Drug: methylcellulose
overencapsulated methylcellulose 3 tablets bd for 6 weeks

Behavioral: CBT website with minimal support
Placebo Comparator: placebo + CBT website minimal support
placebo tablets and access to website
 Drug: placebo
overencapsulated placebo tablets 1 tds for 6 weeks

Behavioral: CBT website with minimal support
Active Comparator: mebeverine + CBT website with support
mebeverine 135mg tds and access to website with nurse support session
 Drug: mebeverine
overencapsulated mebeverine 135 mg tds for 6 weeks

Behavioral: CBT website with support
cognitive behavioral therapy with nurse telephone session and email support
Active Comparator: methylcellulose + CBT website support
methylcellulose 3 tablets twice a day and access to website with nurse support
 Drug: methylcellulose
overencapsulated methylcellulose 3 tablets bd for 6 weeks

Behavioral: CBT website with support
cognitive behavioral therapy with nurse telephone session and email support
Placebo Comparator: placebo + CBT website with support
placebo tablets and access to website with nurse support
 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


Outcome Measures
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Primary Outcome Measures :
  1. IBS Symptom Severity Score [ Time Frame: Baseline, 6 and 12 weeks ]
  2. IBS QOL [ Time Frame: Baseline, 6 and 12 weeks ]
    Quality of life


Secondary Outcome Measures :
  1. Subjects Global Assessment of relief [ Time Frame: 6 weeks and 12 weeks ]
    Subjects global assessment of relief

  2. Enablement [ Time Frame: 6 and 12 weeks ]
    Assessment of Enablement

  3. HADs [ Time Frame: Baseline, 6 and 12 weeks ]
    Hospital Anxiety and Depression Score


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients aged 16 to 60 years with symptoms of irritable bowel syndrome that fulfill the Rome III criteria

Exclusion Criteria:

  • Atypical symptoms (unexplained weight loss, rectal bleeding)
  • Diagnosis of inflammatory bowel disease, coeliac disease or peptic ulcer disease
  • Pregnant or breast feeding
  • Currently taking or allergy to mebeverine or methylcellulose
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00934973


Locations
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United Kingdom
University of Southampton
Southampton, Hampshire, United Kingdom, SO17 1JB
Sponsors and Collaborators
Hazel Everitt
National Institute for Health Research, United Kingdom
Investigators
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Principal Investigator: Hazel A Everitt, MBChB University of Southampton
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

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Responsible Party: Hazel Everitt, Principal Investigator, University of Southampton
ClinicalTrials.gov Identifier: NCT00934973    
Other Study ID Numbers: 5953
2009-013426-16 ( EudraCT Number )
First Posted: July 8, 2009    Key Record Dates
Last Update Posted: April 30, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hazel Everitt, University of Southampton:
irritable bowel syndrome
treatment
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Mebeverine
Alverine
Anticonvulsants
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs