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

Utah System of Higher Education (USHE)

Status and phase: Completed; Phase 3

Conditions: Irritable Bowel Syndrome

Treatments: Drug: Mesalamine; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01412372

39402

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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61 participants in 2 patient groups

Placebo

Experimental group

Description:

This arm will include those who are randomized to the placebo

Treatment:

Drug: Placebo

Mesalamine

Experimental group

Description:

This arm is for subjects randomized to the study drug, Mesalamine

Treatment:

Drug: Mesalamine