Irritable Bowel SyndromePhase 4MIBSNCT00934973
Management of Irritable Bowel Syndrome in Primary Care (MIBS Trial)
A Phase 4 study testing mebeverine, methylcellulose and CBT website with support in people with Irritable Bowel Syndrome, run by Hazel Everitt at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- mebeverine, methylcellulose and CBT website with support
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2010to Oct 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients aged 16 to 60 years with symptoms of irritable bowel syndrome that fulfill the Rome III criteria
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Southampton
Southampton, Hampshire, SO17 1JB
About this study
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)
Aims:
- 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.
- 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).
Read the 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.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- mebeverine, methylcellulose, placebo, CBT website with support, No website
- Keywords
- irritable bowel syndrome, treatment
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mebeverineDrug
overencapsulated mebeverine 135 mg tds for 6 weeks
methylcelluloseDrug
overencapsulated methylcellulose 3 tablets bd for 6 weeks
placeboDrug
overencapsulated placebo tablets 1 tds for 6 weeks
CBT website with supportBehavioural
cognitive behavioral therapy with nurse telephone session and email support
No websiteBehavioural
No CBT website
CBT website with minimal supportBehavioural
| Study group | Role | What they receive |
|---|---|---|
| mebeverine + no website | Active comparator | Mebeverine 135mg tds for 6 weeks Receives: Drug: mebeverine; Behavioral: No website |
| methylcellulose + no website | Active comparator | methylcellulose 3 tablets twice a day for 6 weeks Receives: Drug: methylcellulose; Behavioral: No website |
| placebo + no website | Placebo comparator | placebo tablets Receives: Drug: placebo; Behavioral: No website |
| mebeverine + CBT website minimal support | Active comparator | mebeverine 135mg tds and access to website Receives: Drug: mebeverine; Behavioral: CBT website with minimal support |
| methylcellulose + CBT website | Active comparator | methylellulose 3 tablets twice a day and access to website Receives: Drug: methylcellulose; Behavioral: CBT website with minimal support |
| placebo + CBT website minimal support | Placebo comparator | placebo tablets and access to website Receives: Drug: placebo; Behavioral: CBT website with minimal support |
| mebeverine + CBT website with support | Active comparator | mebeverine 135mg tds and access to website with nurse support session Receives: Drug: mebeverine; Behavioral: CBT website with support |
| methylcellulose + CBT website support | Active comparator | methylcellulose 3 tablets twice a day and access to website with nurse support Receives: Drug: methylcellulose; Behavioral: CBT website with support |
| placebo + CBT website with support | Placebo comparator | placebo tablets and access to website with nurse support Receives: Drug: placebo; Behavioral: CBT website with support |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBS Symptom Severity Score
Measured: Baseline, 6 and 12 weeks
IBS QOL
Quality of life
Measured: Baseline, 6 and 12 weeks
Secondary outcomes (3)
Subjects Global Assessment of relief
Subjects global assessment of relief
Measured: 6 weeks and 12 weeks
Enablement
Assessment of Enablement
Measured: 6 and 12 weeks
HADs
Hospital Anxiety and Depression Score
Measured: Baseline, 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startApr 2010
- Primary completionSep 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hazel Everitt
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor-investigator, Hazel Everitt, University of Southampton
- Investigators
- Hazel A Everitt, MBChB, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00934973
- Sponsor's protocol ID
- 5953
- Other IDs
- 2009-013426-16, 2009
- Acronym
- MIBS
- Status last verified
- Apr 2021
- First submitted
- 29 Jun 2009
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 23602047Everitt 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.
PubMed 21087463
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00934973
- Acronym / sponsor ID
- MIBS / 5953
- Conditions
- Irritable Bowel Syndrome
- Keywords
- irritable bowel syndrome, treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Hazel EverittUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Apr 2010 (actual)
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 8 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aims:
- 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.
- 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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| mebeverine + no website | Active comparator | Drug: mebeverine, Behavioral: No websiteMebeverine 135mg tds for 6 weeks |
| methylcellulose + no website | Active comparator | Drug: methylcellulose, Behavioral: No websitemethylcellulose 3 tablets twice a day for 6 weeks |
| placebo + no website | Placebo comparator | Drug: placebo, Behavioral: No websiteplacebo tablets |
| mebeverine + CBT website minimal support | Active comparator | Drug: mebeverine, Behavioral: CBT website with minimal supportmebeverine 135mg tds and access to website |
| methylcellulose + CBT website | Active comparator | Drug: methylcellulose, Behavioral: CBT website with minimal supportmethylellulose 3 tablets twice a day and access to website |
| placebo + CBT website minimal support | Placebo comparator | Drug: placebo, Behavioral: CBT website with minimal supportplacebo tablets and access to website |
| mebeverine + CBT website with support | Active comparator | Drug: mebeverine, Behavioral: CBT website with supportmebeverine 135mg tds and access to website with nurse support session |
| methylcellulose + CBT website support | Active comparator | Drug: methylcellulose, Behavioral: CBT website with supportmethylcellulose 3 tablets twice a day and access to website with nurse support |
| placebo + CBT website with support | Placebo comparator | Drug: placebo, Behavioral: CBT website with supportplacebo tablets and access to website with nurse support |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients aged 16 to 60 years with symptoms of irritable bowel syndrome that fulfill the Rome III criteria
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mebeverineoverencapsulated mebeverine 135 mg tds for 6 weeks | Drug | mebeverine + CBT website minimal support, mebeverine + CBT website with support, mebeverine + no website |
| methylcelluloseoverencapsulated methylcellulose 3 tablets bd for 6 weeks | Drug | methylcellulose + CBT website, methylcellulose + CBT website support, methylcellulose + no website |
| placebooverencapsulated placebo tablets 1 tds for 6 weeks | Drug | placebo + CBT website minimal support, placebo + CBT website with support, placebo + no website |
| CBT website with supportcognitive behavioral therapy with nurse telephone session and email support | Behavioural | mebeverine + CBT website with support, methylcellulose + CBT website support, placebo + CBT website with support |
| No websiteNo CBT website | Behavioural | mebeverine + no website, methylcellulose + no website, placebo + no website |
| CBT website with minimal support | Behavioural | mebeverine + CBT website minimal support, methylcellulose + CBT website, placebo + CBT website minimal support |
Primary outcome
IBS Symptom Severity Score
Time frame: Baseline, 6 and 12 weeks
IBS QOL
Time frame: Baseline, 6 and 12 weeks
Quality of life
3 secondary outcomes
Subjects Global Assessment of relief
Time frame: 6 weeks and 12 weeks
Enablement
Time frame: 6 and 12 weeks
HADs
Time frame: Baseline, 6 and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Results publication: PubMed 23602047Everitt 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.
- Results publication: PubMed 21087463Everitt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hazel A Everitt, MBChB principal investigator
University of Southampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing mebeverine, methylcellulose and CBT website with support in people with Irritable Bowel Syndrome, run by Hazel Everitt at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IBS Symptom Severity Score (time frame: Baseline, 6 and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00934973, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.