Management of Irritable Bowel Syndrome in Primary Care (MIBS Trial)
MIBS
2 other identifiers
interventional
135
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2009
CompletedFirst Posted
Study publicly available on registry
July 8, 2009
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedApril 30, 2021
April 1, 2021
1.4 years
June 29, 2009
April 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
IBS Symptom Severity Score
Baseline, 6 and 12 weeks
IBS QOL
Quality of life
Baseline, 6 and 12 weeks
Secondary Outcomes (3)
Subjects Global Assessment of relief
6 weeks and 12 weeks
Enablement
6 and 12 weeks
HADs
Baseline, 6 and 12 weeks
Study Arms (9)
mebeverine + no website
ACTIVE COMPARATORMebeverine 135mg tds for 6 weeks
methylcellulose + no website
ACTIVE COMPARATORmethylcellulose 3 tablets twice a day for 6 weeks
placebo + no website
PLACEBO COMPARATORplacebo tablets
mebeverine + CBT website minimal support
ACTIVE COMPARATORmebeverine 135mg tds and access to website
methylcellulose + CBT website
ACTIVE COMPARATORmethylellulose 3 tablets twice a day and access to website
placebo + CBT website minimal support
PLACEBO COMPARATORplacebo tablets and access to website
mebeverine + CBT website with support
ACTIVE COMPARATORmebeverine 135mg tds and access to website with nurse support session
methylcellulose + CBT website support
ACTIVE COMPARATORmethylcellulose 3 tablets twice a day and access to website with nurse support
placebo + CBT website with support
PLACEBO COMPARATORplacebo tablets and access to website with nurse support
Interventions
overencapsulated mebeverine 135 mg tds for 6 weeks
overencapsulated methylcellulose 3 tablets bd for 6 weeks
overencapsulated placebo tablets 1 tds for 6 weeks
cognitive behavioral therapy with nurse telephone session and email support
No CBT website
Eligibility Criteria
You may qualify if:
- Patients aged 16 to 60 years with symptoms of irritable bowel syndrome that fulfill the Rome III criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Southampton
Southampton, Hampshire, SO17 1JB, United Kingdom
Related 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-management website. BMC Gastroenterol. 2013 Apr 21;13:68. doi: 10.1186/1471-230X-13-68.
PMID: 23602047RESULTEveritt 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.
PMID: 21087463RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hazel A Everitt, MBChB
University of Southampton
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 29, 2009
First Posted
July 8, 2009
Study Start
April 1, 2010
Primary Completion
September 1, 2011
Study Completion
October 1, 2011
Last Updated
April 30, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share