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

Irritable Bowel Syndrome Clinical Trial

— MIBS  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00934973
• Other study ID #: 5953
• Secondary ID: 2009-013426-16
• Status: Completed
• Phase: Phase 4
• Start date: April 2010
• Est. completion date: October 2011

Study information

• Verified date: April 2021
• Source: University of Southampton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• 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

Behavioral:
• CBT website with support
cognitive behavioral therapy with nurse telephone session and email support
• No website
No CBT website
• CBT website with minimal support

Locations

Country	Name	City	State
United Kingdom	University of Southampton	Southampton	Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Hazel Everitt	National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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-mana — View Citation

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-managemen — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IBS Symptom Severity Score		Baseline, 6 and 12 weeks
Primary	IBS QOL	Quality of life	Baseline, 6 and 12 weeks
Secondary	Subjects Global Assessment of relief	Subjects global assessment of relief	6 weeks and 12 weeks
Secondary	Enablement	Assessment of Enablement	6 and 12 weeks
Secondary	HADs	Hospital Anxiety and Depression Score	Baseline, 6 and 12 weeks