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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
  Purpose

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.


Condition Intervention Phase
Post Infective IBS-D
Irritable Bowel Syndrome With Diarrhea
 Drug: Mesalamine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 68
Study Start Date: June 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Placebo
This arm will include those who are randomized to the placebo
 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: Mesalamine
This arm is for subjects randomized to the study drug, Mesalamine
 Drug: Mesalamine
2 1.2g tablets once daily for 8 weeks. Patients randomized 50/50 to either Mesalamine or the Placebo
Other Name: Lialda

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01412372

Contacts
Contact: Andrew Grandemange 801-587-9092 Andrew.Grandemange@hsc.utah.edu
Contact: Ashok Tuteja 801-587-3453 Ashok.Tuteja@hsc.utah.edu

Locations
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Andrew Grandemange     801-587-9092     Andrew.Grandemange@hsc.utah.edu    
Principal Investigator: Ashok Tuteja, M.D.            
Sponsors and Collaborators
University of Utah
Shire Human Genetic Therapies, Inc.
Investigators
Principal Investigator: Ashok Tuteja Gastroenterology
  More Information

No publications provided

Responsible Party: Associate Professor (Clinical) Ashok Tuteja, Gastroenterology
ClinicalTrials.gov Identifier: NCT01412372     History of Changes
Other Study ID Numbers: 39402
Study First Received: June 24, 2011
Last Updated: June 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Irritable Bowel Syndrome
Diarrhea
Mesalamine
 Gastroenteritis
abdominal pain
hypersensitivity

Additional relevant MeSH terms:
Diarrhea
Irritable Bowel Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013