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

• Status: Completed
• Trial end date: 2019-04-22
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Collaborator: Shire Human Genetic Therapies, Inc.
• Treatments: Mesalamine

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