Irritable Bowel Syndrome With DiarrhoeaPhase 4MIBSNCT01316718
Mesalazine for the Treatment of Diarrhoea-predominant Irritable Bowel Syndrome (IBS-D)
A Phase 4 study testing Mesalazine in people with Irritable Bowel Syndrome With Diarrhoea, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
The purpose of the trial is to define the clinical benefit and possible mediators of the benefit of mesalazine in Irritable Bowel Syndrome (IBS) with diarrhoea. The investigators will therefore evaluate symptoms (primarily bowel frequency) and markers reflecting mast cell activation and small bowel tone. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome With Diarrhoea
- What is being tested?
- Mesalazine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2011to Sep 2013
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female patients aged 18-75 years old able to give informed consent.
- Patients should all have had a colonoscopy or a sigmoidoscopy within the last 12 months to exclude microscopic colitis. (If not, but they have had a negative colonoscopy within 5 years and symptoms are unchanged, then a sigmoidoscopy and mucosal biopsy of the left colon would be sufficient to exclude microscopic colitis).
- IBS-D Patients meeting Rome III criteria prior to screening phase.
- Patients with ≥ 25% soft (score > 4) and < 25% hard (score 1 or 2) stools during the screening phase, as scored by the daily symptom and stool diary*.
- Patients with a stool frequency of 3 or more per day for 2 or more days per week during the screening phase*.
- Satisfactory completion of the daily stool and symptom diary during the screening phase at the discretion of the investigator.
- Women of child bearing potential willing or able to use at least one highly effective contraceptive method throughout the study. In the context of this study, an effective method is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly such as: implants, injectables, combined oral contraceptives, sexual abstinence or vasectomised partner.
- If inclusion criterion 4 and/or 5 is/are not met but the results are considered atypical (as observed from medical history and patient recall) then the patient can be re-screen on 1 occasion only.
Who cannot join
- Women who are pregnant or breast feeding
- Prior abdominal surgery which may cause bowel symptoms similar to IBS (note appendectomy and cholecystectomy will not be an exclusion)
- Patients unable to stop anti-muscarinics, anti-spasmodics, high dose tricyclic antidepressants (i.e. above 50 mg/day), opiates/anti-diarrhoeal drugs*, NSAIDs (occasional over the counter use and topical formulations are allowed), long-term antibiotics, other anti-inflammatory drugs or 5-ASA containing drugs.
- Patients on selective serotonin re-uptake inhibitors and low dose tricyclic antidepressants (i.e. up to 50 mg/day) for at least 3 months previous unwilling to remain on a stable dose for the duration of the trial.
- Patients with other gastro-intestinal diseases including colitis and Crohn's disease.
- Patients with the following conditions: Renal impairment, severe hepatic impairment or salicylate hypersensitivity.
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- Patients currently participating in another trial or have been in a trial within the previous 3 months
- Patients who in the opinion of the investigator are considered unsuitable due to inability to comply with instructions
- Patients with serious concomitant diseases e.g. cardiovascular, respiratory, neurological etc.
- Loperamide is allowed as rescue medication through-out the trial, however if > 2 doses / week are taken during the screening phase then they are not eligible, though they can be re-screened on 1 occasion only.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Mode of Action of Mesalazine in the Treatment of Diarrhoea-predominant Irritable Bowel Syndrome (IBS-D).
The purpose of the trial is to define the clinical benefit and possible mediators of the benefit of mesalazine in Irritable Bowel Syndrome (IBS) with diarrhoea.
The investigators will therefore evaluate symptoms (primarily bowel frequency) and markers reflecting mast cell activation and small bowel tone.
- Conditions
- Irritable Bowel Syndrome With Diarrhoea
- Being tested
- Mesalazine, Placebo
- Keywords
- IBS, diarrhoea
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MesalazineDrug
2g oral granules, once a day for 1 week, then 2g oral granules, twice a day for 11 weeks
PlaceboDrug
2g oral granules, once a day for 1 week, then 2g oral granules, twice a day for 11 weeks
| Study group | Role | What they receive |
|---|---|---|
| Mesalazine Granules | Experimental | 2g oral granules, once a day for 1 week, then 2g oral granules, twice a day for 11 weeks Receives: Drug: Mesalazine |
| Placebo Granules | Placebo comparator | 2g oral granules, once a day for 1 week, then 2g oral granules, twice a day for 11 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in average stool frequency during weeks 11 and 12.
Clinical Endpoint
Measured: Week 0 and week 12
Change from baseline of number of mast cell per mm2 at week 12
Mechanistic endpoint
Measured: Week 0 and week 12
Secondary outcomes (11)
Average daily severity of abdominal pain on a 0-10 scale
Clinical Endpoint
Measured: Week 0 to week 12
Days with urgency
Clinical Endpoint
Measured: weeks 11-12
Mean stool consistency using Bristol Stool Form Score
Clinical Endpoint
Measured: Week 0 to week 12
Global satisfaction with control of IBS symptoms
as assessed from the answer to the question "Have you had satisfactory relief of your IBS symptoms this week? Yes / No. "
Measured: Week 0 to week 12
Mast cell tryptase release during 6 hour biopsy incubation
Mechanistic endpoint
Measured: Week 0 and week 12
IL-1β, TNF-a, histamine and serotonin secretion during same incubation
Mechanistic endpoint
Measured: Week 0 and week 12
Small bowel tone assessed by volume of fasting small bowel water
Mechanistic endpoint
Measured: Week 0 and week 12
Euro-Qol Score
Ancillary endpoint
Measured: Week 0 and week 12
Centres for disease control and prevention health related quality of life healthy days core module score
Ancillary endpoint
Measured: Week 0 and week 12
Hospital Anxiety Depression Scale Score
Ancillary endpoint
Measured: Week 0 and week 12
Patient Health Questionnaire -15
Ancillary endpoint
Measured: Week 0 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel Syndrome With DiarrhoeaStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Robin C Spiller, MD, Principal investigator, NIHR Biomedical Research Unit, Nottingham University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01316718
- Sponsor's protocol ID
- 10085
- Acronym
- MIBS
- Status last verified
- Jan 2014
- First submitted
- 21 Sep 2010
- Last updated
- 17 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lam C, Tan W, Leighton M, Hastings M, Lingaya M, Falcone Y, Zhou X, Xu L, Whorwell P, Walls AF, Zaitoun A, Montgomery A, Spiller R. A mechanistic multicentre, parallel group, randomised placebo-controlled trial of mesalazine for the treatment of IBS with diarrhoea (IBS-D). Gut. 2016 Jan;65(1):91-9. doi: 10.1136/gutjnl-2015-309122. Epub 2015 Mar 12.
PubMed 25765462
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Mode of Action of Mesalazine in the Treatment of Diarrhoea-predominant Irritable Bowel Syndrome (IBS-D).
- ClinicalTrials.gov ID
- NCT01316718
- Acronym / sponsor ID
- MIBS / 10085
- Conditions
- Irritable Bowel Syndrome With Diarrhoea
- Keywords
- IBS, diarrhoea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Mar 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 16 Mar 2011 (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.
The purpose of the trial is to define the clinical benefit and possible mediators of the benefit of mesalazine in Irritable Bowel Syndrome (IBS) with diarrhoea.
The investigators will therefore evaluate symptoms (primarily bowel frequency) and markers reflecting mast cell activation and small bowel tone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesalazine Granules | Experimental | Drug: Mesalazine2g oral granules, once a day for 1 week, then 2g oral granules, twice a day for 11 weeks |
| Placebo Granules | Placebo comparator | Drug: Placebo2g oral granules, once a day for 1 week, then 2g oral granules, twice a day for 11 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or Female patients aged 18-75 years old able to give informed consent.
- Patients should all have had a colonoscopy or a sigmoidoscopy within the last 12 months to exclude microscopic colitis. (If not, but they have had a negative colonoscopy within 5 years and symptoms are unchanged, then a sigmoidoscopy and mucosal biopsy of the left colon would be sufficient to exclude microscopic colitis).
- IBS-D Patients meeting Rome III criteria prior to screening phase.
- Patients with ≥ 25% soft (score > 4) and < 25% hard (score 1 or 2) stools during the screening phase, as scored by the daily symptom and stool diary*.
- Patients with a stool frequency of 3 or more per day for 2 or more days per week during the screening phase*.
Key exclusion criteria (10 listed)
- Women who are pregnant or breast feeding
- Prior abdominal surgery which may cause bowel symptoms similar to IBS (note appendectomy and cholecystectomy will not be an exclusion)
- Patients unable to stop anti-muscarinics, anti-spasmodics, high dose tricyclic antidepressants (i.e. above 50 mg/day), opiates/anti-diarrhoeal drugs*, NSAIDs (occasional over the counter use and topical formulations are allowed), long-term antibiotics, other anti-inflammatory drugs or 5-ASA containing drugs.
- Patients on selective serotonin re-uptake inhibitors and low dose tricyclic antidepressants (i.e. up to 50 mg/day) for at least 3 months previous unwilling to remain on a stable dose for the duration of the trial.
- Patients with other gastro-intestinal diseases including colitis and Crohn's disease.
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 |
|---|---|---|
| Mesalazine2g oral granules, once a day for 1 week, then 2g oral granules, twice a day for 11 weeks | Drug | Mesalazine Granules |
| Placebo2g oral granules, once a day for 1 week, then 2g oral granules, twice a day for 11 weeks | Drug | Placebo Granules |
Primary outcome
Change from baseline in average stool frequency during weeks 11 and 12.
Time frame: Week 0 and week 12
Clinical Endpoint
Change from baseline of number of mast cell per mm2 at week 12
Time frame: Week 0 and week 12
Mechanistic endpoint
11 secondary outcomes
Average daily severity of abdominal pain on a 0-10 scale
Time frame: Week 0 to week 12
Days with urgency
Time frame: weeks 11-12
Mean stool consistency using Bristol Stool Form Score
Time frame: Week 0 to week 12
Global satisfaction with control of IBS symptoms
Time frame: Week 0 to week 12
Mast cell tryptase release during 6 hour biopsy incubation
Time frame: Week 0 and week 12
IL-1β, TNF-a, histamine and serotonin secretion during same incubation
Time frame: Week 0 and week 12
Small bowel tone assessed by volume of fasting small bowel water
Time frame: Week 0 and week 12
Euro-Qol Score
Time frame: Week 0 and week 12
Centres for disease control and prevention health related quality of life healthy days core module score
Time frame: Week 0 and week 12
Hospital Anxiety Depression Scale Score
Time frame: Week 0 and week 12
Patient Health Questionnaire -15
Time frame: Week 0 and week 12
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 17 Jan 2014.
- Derived from this study: PubMed 25765462Lam C, Tan W, Leighton M, Hastings M, Lingaya M, Falcone Y, Zhou X, Xu L, Whorwell P, Walls AF, Zaitoun A, Montgomery A, Spiller R. A mechanistic multicentre, parallel group, randomised placebo-controlled trial of mesalazine for the treatment of IBS with diarrhoea (IBS-D). Gut. 2016 Jan;65(1):91-9. doi: 10.1136/gutjnl-2015-309122. Epub 2015 Mar 12.
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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.
Robin C Spiller, MD principal investigator
NIHR Biomedical Research Unit, Nottingham University
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 Mesalazine in people with Irritable Bowel Syndrome With Diarrhoea, run by University of Nottingham 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 8 inclusion and 10 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 17 Jan 2014. 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?
Change from baseline in average stool frequency during weeks 11 and 12. (time frame: Week 0 and week 12). 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 NCT01316718, which also lists 1 linked publication.
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 17 Jan 2014.