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

Completed · Phase 3 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome

In brief

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.

Key facts

Study ID

NCT01412372

Run by

University of Utah

People needed

61

Starts

2010-06-01

Expected to finish

2019-04-22

Last updated by the study team

2020-12-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Age <18 or >75 years
• Previous diagnosis of or history compatible with IBS
• Constipation-predominant IBS.
• Clinically significant chronic cardiac, pulmonary, hepatic, renal dysfunction or HIV
• History of/or presence of malignancy
• 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. .
• Current evidence of drug or alcohol abuse as judged by the investigator
• Allergy to mesalamine or aspirin
• Investigator perception of patient's inability to comply with the study protocol
• Unstable psychiatric disease
• Recent change in gastrointestinal medications

Where it is running

• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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