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

This study has been completed.
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Hazel Everitt, University of Southampton
ClinicalTrials.gov Identifier:
NCT00934973
First received: June 29, 2009
Last updated: January 16, 2013
Last verified: January 2013

June 29, 2009
January 16, 2013
April 2010
September 2011   (final data collection date for primary outcome measure)
  • IBS Symptom Severity Score [ Time Frame: Baseline, 6 and 12 weeks ] [ Designated as safety issue: No ]
  • IBS QOL [ Time Frame: Baseline, 6 and 12 weeks ] [ Designated as safety issue: No ]
    Quality of life
Same as current
Complete list of historical versions of study NCT00934973 on ClinicalTrials.gov Archive Site
  • Subjects Global Assessment of relief [ Time Frame: 6 weeks and 12 weeks ] [ Designated as safety issue: No ]
    Subjects global assessment of relief
  • Enablement [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: No ]
    Assessment of Enablement
  • HADs [ Time Frame: Baseline, 6 and 12 weeks ] [ Designated as safety issue: No ]
    Hospital Anxiety and Depression Score
Not Provided
Not Provided
Not Provided
 
Management of Irritable Bowel Syndrome in Primary Care (MIBS Trial)
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)

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.

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).

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Irritable Bowel Syndrome
  • 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
  • Active Comparator: mebeverine + no website
    Mebeverine 135mg tds for 6 weeks
    Interventions:
    • Drug: mebeverine
    • Behavioral: No website
  • Active Comparator: methylcellulose + no website
    methylcellulose 3 tablets twice a day for 6 weeks
    Interventions:
    • Drug: methylcellulose
    • Behavioral: No website
  • Placebo Comparator: placebo + no website
    placebo tablets
    Interventions:
    • Drug: placebo
    • Behavioral: No website
  • Active Comparator: mebeverine + CBT website minimal support
    mebeverine 135mg tds and access to website
    Interventions:
    • Drug: mebeverine
    • Behavioral: CBT website with minimal support
  • Active Comparator: methylcellulose + CBT website
    methylellulose 3 tablets twice a day and access to website
    Interventions:
    • Drug: methylcellulose
    • Behavioral: CBT website with minimal support
  • Placebo Comparator: placebo + CBT website minimal support
    placebo tablets and access to website
    Interventions:
    • Drug: placebo
    • Behavioral: CBT website with minimal support
  • Active Comparator: mebeverine + CBT website with support
    mebeverine 135mg tds and access to website with nurse support session
    Interventions:
    • Drug: mebeverine
    • Behavioral: CBT website with support
  • Active Comparator: methylcellulose + CBT website support
    methylcellulose 3 tablets twice a day and access to website with nurse support
    Interventions:
    • Drug: methylcellulose
    • Behavioral: CBT website with support
  • Placebo Comparator: placebo + CBT website with support
    placebo tablets and access to website with nurse support
    Interventions:
    • Drug: placebo
    • Behavioral: CBT website with support

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
135
October 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
16 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00934973
5953
No
Hazel Everitt, University of Southampton
Hazel Everitt
National Institute for Health Research, United Kingdom
Principal Investigator: Hazel A Everitt, MBChB University of Southampton
University of Southampton
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP