Overview

Efficacy of Mesalamine in Diarrhea-predominant Irritable Bowel Syndrome (dIBS)

Status:
Completed
Trial end date:
2012-03-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to find whether treating patients with diarrhea predominant Irritable Bowel Syndrome (IBS) with an anti-inflammatory drug called Mesalamine will help improve their symptoms of diarrhea, bloating and abdominal pain.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Florida
Treatments:
Mesalamine
Criteria
Inclusion Criteria:

- Male and female aged 18-65 years old

- Functional Bowel Disorder Severity Index Score above 37

- Normal complete blood count, liver function studies and renal function studies

- Serologies done to rule out Celiac Spure or patient has prior negative EGD with small
bowel biopsies which have been negative

- Infectious diarrhea ruled out by stool studies

- Negative colonoscopy

Exclusion Criteria:

- Any history of chronic liver disease, heart disease, pulmonary or renal disease

- Abnormal EKG

- Women with positive pregnancy tests

- Patient on steroids, antacids, or warfarin or chronic pain conditions other than
fibromyalgia

- Patients who drink over 2oz alcohol/day on a regular basis Any other causes for
diarrhea such as IBD, microscopic colitis, celiac disease, history of abdominal
obstruction, pancreatitis, ileus, or any gastrointestinal bleeding.

- Patients with active malignancy in the past five years

- Patient with any history of hypersensitivity reactions to salicylate containing
medications due to cross-sensitivity with mesalamine or allergy to mesalamine
medications in the past

- Any subjects with fibromyalgia will be excluded from the pain testing portion only

- History of Phenylketonuria due to the aspartame contained in Apriso