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

Completed · Phase 2 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome

In brief

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.

Key facts

Study ID

NCT01327300

Run by

University of Florida

People needed

7

Starts

2010-03-01

Expected to finish

2012-03-01

Last updated by the study team

2014-02-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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