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The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study

This study is currently recruiting participants.
Verified June 2012 by University of Utah
Sponsor:
Collaborator:
Shire Human Genetic Therapies, Inc.
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT01412372
First received: June 24, 2011
Last updated: June 4, 2012
Last verified: June 2012
History of Changes

June 24, 2011
June 4, 2012
June 2010
December 2012   (final data collection date for primary outcome measure)
Change from baseline in gastrointestinal symptoms and IBS specific quality of life after an 8 week treatment period [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
NF-κB (nuclear factor kappa-light chain-enhancer of activated B cells) is a transcription factor that plays a central role in inflammation and immune regulation. Mesalamine (5-ASA) is a PPARγ (peroxisome proliferator-activated receptor γ) agonist which among other things inhibits NF- κB. There is anecdotal evidence that it is effective in the treatment of microscopic colitis which has many pathophysiologic similarities to PI-IBS. We hypothesize that patients with PI-IBS are also likely to respond to Mesalamine.
Change from baseline in gastrointestinal symptoms, IBS specific quality of life after an 8 weak treatment period [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
NF-κB (nuclear factor kappa-light chain-enhancer of activated B cells) is a transcription factor that plays a central role in inflammation and immune regulation. Mesalamine (5-ASA) is a PPARγ (peroxisome proliferator-activated receptor γ) agonist which among other things inhibits NF- κB. There is anecdotal evidence that it is effective in the treatment of microscopic colitis which has many pathophysiologic similarities to PI-IBS. We hypothesize that patients with PI-IBS are also likely to respond to Mesalamine.
Complete list of historical versions of study NCT01412372 on ClinicalTrials.gov Archive Site
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The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study
The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study

The purpose of this study is to evaluate the effects of long acting mesalamine (Lialda) in patients with Post-Infective Irritable Bowel Syndrome (PI-IBS). The investigators will evaluate gastrointestinal symptoms, IBS specific quality of life (IBS-QOL), and plasma cytokines before and after treatment with Lialda.

This study will test long acting mesalamine in the management of PI-IBS. It has the potential to improve QOL and perhaps gastrointestinal symptoms, in patients with PI-IBS. The results of this study, if positive, will provide preliminary data for a large scale clinical trial.

This study will also provide information about plasma cytokines in patients with PI-IBS and whether improvement in symptoms correlates with improvement in plasma cytokines.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Post Infective IBS-D
  • Irritable Bowel Syndrome With Diarrhea
Drug: Mesalamine
2 1.2g tablets once daily for 8 weeks. Patients randomized 50/50 to either Mesalamine or the Placebo
Other Name: Lialda
  • Experimental: Placebo
    This arm will include those who are randomized to the placebo
    Intervention: Drug: Mesalamine
  • Experimental: Mesalamine
    This arm is for subjects randomized to the study drug, Mesalamine
    Intervention: Drug: Mesalamine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
68
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

Inclusion Criteria

  1. Men and women age 18-75 years
  2. Rome III criteria for IBS
  3. Symptom onset after apparent acute gastroenteritis
  4. Symptoms of 6 months or greater duration
  5. Normal gross appearance of the colonic mucosa other than erythema
  6. Negative markers for celiac disease and inflammatory bowel disease
  7. Normal thyroid function and serum calcium
  8. Stable medication regimens for other medical conditions.

Exclusion Criteria:

  1. Age <18 or >75 years
  2. Previous diagnosis of or history compatible with IBS
  3. Constipation-predominant IBS.
  4. Clinically significant chronic cardiac, pulmonary, hepatic, renal dysfunction or HIV
  5. History of/or presence of malignancy
  6. Current evidence of any gastrointestinal disorder such as celiac disease, inflammatory bowel disease, chronic pancreatitis, scleroderma, HIV, small bowel or colonic resection, paraplegia or quadriplegia. .
  7. Current evidence of drug or alcohol abuse as judged by the investigator
  8. Allergy to mesalamine or aspirin
  9. Investigator perception of patient's inability to comply with the study protocol
  10. Unstable psychiatric disease
  11. Recent change in gastrointestinal medications
Both
18 Years to 75 Years
No
Contact: Andrew Grandemange 801-587-9092 Andrew.Grandemange@hsc.utah.edu
Contact: Ashok Tuteja 801-587-3453 Ashok.Tuteja@hsc.utah.edu
United States
 
NCT01412372
39402
Yes
Associate Professor (Clinical) Ashok Tuteja, Gastroenterology
University of Utah
Shire Human Genetic Therapies, Inc.
Principal Investigator: Ashok Tuteja Gastroenterology
University of Utah
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP