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