NCT01114113

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

Pilot Study: Assessment of Gastric and Intestinal Motility Following a Trigger Meal in Patients With Post Prandial Diarrhea

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Money, Mary E., M.D. · Individual
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Irritable Bowel Syndrome
• Diarrhea

Interventions

Type	Name	Description
DRUG	pancelipase/placebo	ZenPep 20000 units of lipase will be provided for the participant to take with a trigger meal or an identical placebo. This will only be given to those participants willing to consume 2 more identical "trigger meals" and will not be given for the initial baseline "non-trigger" and baseline "trigger meal". In both of these arms, patients will also be swallowing the SmartPill Capsule.
DEVICE	SmartPill capsule	Measurement of a baseline, non-trigger meal intestinal transit by using the SmartPill capsule.
DEVICE	SmartPill capsule	Measurement of intestinal transit of a "trigger meal" baseline by using the SmartPill capsule
DEVICE	SmartPill capsule	SmartPill capsule

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2010-04-30
• Last updated: 2012-04-20