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Mesalazine for the Treatment of Diarrhoea-predominant Irritable Bowel Syndrome (IBS-D) (MIBS)

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ClinicalTrials.gov Identifier: NCT01316718
Recruitment Status : Completed
First Posted : March 16, 2011
Last Update Posted : January 17, 2014
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome With Diarrhoea Drug: Mesalazine Drug: Placebo Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Mode of Action of Mesalazine in the Treatment of Diarrhoea-predominant Irritable Bowel Syndrome (IBS-D).
Study Start Date : March 2011
Primary Completion Date : September 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Mesalazine Granules
2g oral granules, once a day for 1 week, then 2g oral granules, twice a day for 11 weeks
Drug: Mesalazine
2g oral granules, once a day for 1 week, then 2g oral granules, twice a day for 11 weeks
Placebo Comparator: Placebo Granules
2g oral granules, once a day for 1 week, then 2g oral granules, twice a day for 11 weeks
Drug: Placebo
2g oral granules, once a day for 1 week, then 2g oral granules, twice a day for 11 weeks

Outcome Measures

Primary Outcome Measures :
  1. Change from baseline in average stool frequency during weeks 11 and 12. [ Time Frame: Week 0 and week 12 ]
    Clinical Endpoint

  2. Change from baseline of number of mast cell per mm2 at week 12 [ Time Frame: Week 0 and week 12 ]
    Mechanistic endpoint

Secondary Outcome Measures :
  1. Average daily severity of abdominal pain on a 0-10 scale [ Time Frame: Week 0 to week 12 ]
    Clinical Endpoint

  2. Days with urgency [ Time Frame: weeks 11-12 ]
    Clinical Endpoint

  3. Mean stool consistency using Bristol Stool Form Score [ Time Frame: Week 0 to week 12 ]
    Clinical Endpoint

  4. Global satisfaction with control of IBS symptoms [ Time Frame: Week 0 to week 12 ]
    as assessed from the answer to the question "Have you had satisfactory relief of your IBS symptoms this week? Yes / No. "

  5. Mast cell tryptase release during 6 hour biopsy incubation [ Time Frame: Week 0 and week 12 ]
    Mechanistic endpoint

  6. IL-1β, TNF-a, histamine and serotonin secretion during same incubation [ Time Frame: Week 0 and week 12 ]
    Mechanistic endpoint

  7. Small bowel tone assessed by volume of fasting small bowel water [ Time Frame: Week 0 and week 12 ]
    Mechanistic endpoint

  8. Euro-Qol Score [ Time Frame: Week 0 and week 12 ]
    Ancillary endpoint

  9. Centres for disease control and prevention health related quality of life healthy days core module score [ Time Frame: Week 0 and week 12 ]
    Ancillary endpoint

  10. Hospital Anxiety Depression Scale Score [ Time Frame: Week 0 and week 12 ]
    Ancillary endpoint

  11. Patient Health Questionnaire -15 [ Time Frame: Week 0 and week 12 ]
    Ancillary endpoint

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or Female patients aged 18-75 years old able to give informed consent.
  2. 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).
  3. IBS-D Patients meeting Rome III criteria prior to screening phase.
  4. 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*.
  5. Patients with a stool frequency of 3 or more per day for 2 or more days per week during the screening phase*.
  6. Satisfactory completion of the daily stool and symptom diary during the screening phase at the discretion of the investigator.
  7. 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.

Exclusion Criteria:

  1. Women who are pregnant or breast feeding
  2. Prior abdominal surgery which may cause bowel symptoms similar to IBS (note appendectomy and cholecystectomy will not be an exclusion)
  3. 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.
  4. 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.
  5. Patients with other gastro-intestinal diseases including colitis and Crohn's disease.
  6. Patients with the following conditions: Renal impairment, severe hepatic impairment or salicylate hypersensitivity.
  7. Patients currently participating in another trial or have been in a trial within the previous 3 months
  8. Patients who in the opinion of the investigator are considered unsuitable due to inability to comply with instructions
  9. 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01316718

United Kingdom
Queen's Medical Centre
Nottingham, Notts, United Kingdom, NG7 2UH
Sponsors and Collaborators
University of Nottingham
National Institute for Health Research, United Kingdom
Principal Investigator: Robin C Spiller, MD NIHR Biomedical Research Unit, Nottingham University
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01316718     History of Changes
Other Study ID Numbers: 10085
First Posted: March 16, 2011    Key Record Dates
Last Update Posted: January 17, 2014
Last Verified: January 2014

Keywords provided by University of Nottingham:

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents