The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study
Status: | Recruiting |
---|---|
Conditions: | Irritable Bowel Syndrome (IBS), Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 10/28/2018 |
Start Date: | June 2010 |
End Date: | December 2019 |
Contact: | Jaya Vijayan, M.B.B.S. |
Email: | jaya.vijayan@hsc.utah.edu |
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.
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.
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.
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
We found this trial at
1
site
201 Presidents Circle
Salt Lake City, Utah 84108
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Ashok Tuteja, M.D.
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