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

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)

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).

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Drug: mebeverine; Behavioral: No website; Drug: methylcellulose; Drug: placebo; Behavioral: CBT website with minimal support; Behavioral: CBT website with support

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 Type: Interventional
• Enrollment (Actual): 135
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO17 1JB
      • University of Southampton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

9

Arms and Interventions

Participant Group / 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	Behavioral: No website; No CBT website; Drug: methylcellulose; overencapsulated methylcellulose 3 tablets bd for 6 weeks
Placebo Comparator: placebo + no website; placebo tablets	Behavioral: No website; No CBT website; Drug: placebo; overencapsulated placebo tablets 1 tds for 6 weeks
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IBS Symptom Severity Score		Baseline, 6 and 12 weeks
IBS QOL	Quality of life	Baseline, 6 and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjects Global Assessment of relief	Subjects global assessment of relief	6 weeks and 12 weeks
Enablement	Assessment of Enablement	6 and 12 weeks
HADs	Hospital Anxiety and Depression Score	Baseline, 6 and 12 weeks

Collaborators and Investigators

• Sponsor: Hazel Everitt
• Collaborators: National Institute for Health Research, United Kingdom
• Investigators: Principal Investigator: Hazel A Everitt, MBChB, University of Southampton

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2010
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: June 29, 2009
• First Submitted That Met QC Criteria: July 7, 2009
• First Posted (Estimate): July 8, 2009

Study Record Updates

• Last Update Posted (Actual): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: treatment; irritable bowel syndrome
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Physiological Effects of Drugs; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Anticonvulsants; Mebeverine; Alverine
• Other Study ID Numbers: 5953; 2009-013426-16 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No