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

NCT01114113 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2012-04-20

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Money, Mary E., M.D.

    lead INDIV

Principal Investigators

  • Mary E Money, M.D. · Washington County Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-01-31
Completion
2011-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01114113 on ClinicalTrials.gov