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Trial record 9 of 15 for:    IBS and CBT

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
  Purpose

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.


Condition Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by University of Southampton:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 135
Study Start Date: April 2010
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00934973

Locations
United Kingdom
University of Southampton
Southampton, Hampshire, United Kingdom, SO17 1JB
Sponsors and Collaborators
Hazel Everitt
National Institute for Health Research, United Kingdom
Investigators
Principal Investigator: Hazel A Everitt, MBChB University of Southampton
  More Information

No publications provided by University of Southampton

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hazel Everitt, Principal Investigator, University of Southampton
ClinicalTrials.gov Identifier: NCT00934973     History of Changes
Other Study ID Numbers: 5953
Study First Received: June 29, 2009
Last Updated: January 16, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Southampton:
irritable bowel syndrome
treatment

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Disease
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes
Alverine
Mebeverine
Anticonvulsants
Autonomic Agents
Central Nervous System Agents
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014