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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by University of Utah
Shire Human Genetic Therapies, Inc.
Information provided by (Responsible Party):
Ashok K. Tuteja, University of Utah Identifier:
First received: June 24, 2011
Last updated: February 9, 2016
Last verified: February 2016
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.

Condition Intervention Phase
Irritable Bowel Syndrome
Drug: Mesalamine
Drug: Placebo
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:

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 ]

Estimated Enrollment: 68
Study Start Date: June 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (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: Placebo
This is an inactive pill
Other Name: Inactive drug
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

Detailed Description:

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.


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01412372

Contact: Deva P Gundupalli, MS,MPH

United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Deva P Gundupalli, MS,MPH   
Principal Investigator: Ashok Tuteja, M.D.         
Sponsors and Collaborators
University of Utah
Shire Human Genetic Therapies, Inc.
Principal Investigator: Ashok Tuteja Gastroenterology
  More Information

Responsible Party: Ashok K. Tuteja, Associate professor of medicine, University of Utah Identifier: NCT01412372     History of Changes
Other Study ID Numbers: 39402 
Study First Received: June 24, 2011
Last Updated: February 9, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Irritable Bowel Syndrome
abdominal pain

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on April 27, 2016