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Assessment of Gastric Emptying Speed in Patients Who Experience Diarrhea Following a Trigger Meal

2014-08-27 03:14:05 | BioPortfolio

Summary

The rapid diarrhea that patients experience who have diarrhea occurring after eating specific foods may be causing a "physiologic gastric dumping syndrome". This means that rather than the food being kept in the stomach for normal digestion, it rapidly goes into the small intestine and diarrhea occurs. This study is designed to measure how fast the food empties from the stomach when a person with this problem consumes a "regular diet", compared to a meal with a "triggering substance". Each participant will swallow a radio frequency capsule that with the different meals that will show how fast the food is traveling through the intestines in the different situations.

Description

Since some patients have found that pancreatic enzymes seem to ameliorate this diarrhea from occurring,willing participants will be asked to duplicate the "triggering meal" 2 more times. Once taking a pancreatic enzyme (active drug) with the meal and a second time taking an identical placebo. Neither the participant nor the study investigator will know which capsule is the active drug in this phase of the study. Willing participants will receive a small stipend each time they swallow the radio frequency capsule. This capsule is large, approximately twice the size of a vitamin pill so individuals must have no difficulties with swallow to participate nor any history of bowel obstruction or major surgery to the abdominal which might have caused adhesions.

Study Design

Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Conditions

Irritable Bowel Syndrome

Intervention

pancelipase/placebo, SmartPill capsule, SmartPill capsule, SmartPill capsule

Location

Dr. Mary E. Money
Hagerstown
Maryland
United States
21740

Status

Recruiting

Source

Money, Mary E., M.D.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:05-0400

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