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

Last updated: April 18, 2012
Sponsor: Money, Mary E., M.D.
Overall Status: Trial Not Available

Phase

N/A

Condition

Gastrointestinal Diseases And Disorders

Bowel Dysfunction

Lactose Intolerance

Treatment

N/A

Clinical Study ID

NCT01114113
2010IBS-G/D eval
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The patient must have been diagnosed as having post prandial diarrhea for at least 5years by his/her primary care physician or gastroenterologist and is believed to haveno other medical condition that would cause this medical problem. Each person must beover 18 years old and have negative testing for Celiac Disease, a normal colonoscopywithin 5 years of enrollment, and a normal Hgb and sedimentation rate within 6 monthsof enrollment in the trial.

  2. The patient has provided documented written informed consent/authorization prior toinitiation of any study-related procedure.

  3. In addition, each patient must report experiencing the onset of urgent defecationwithin 1 hours of eating a specific trigger which is reproducible at least 90% of thetime when consume.

  4. The patient must be willing to comply with all of the study protocol.

Exclusion

Exclusion Criteria:

  1. The patient has had any rectal bleeding or bloody stools within the last 2 years notcompletely evaluated by a physician. If rectal bleeding has occurred, and the patientwants to be considered for the study, the diagnostic workup must have clearlyidentified the etiology for the bleeding and excluded the medical conditions listedunder 3 below. The patient must be willing to allow the Study team to obtain theserecords for verification of the diagnosis.

  2. The patient has nocturnal bowel movements.

  3. The patient has been diagnosed with or has a family history of any of the following:ulcerative colitis, Crohn's Disease, celiac disease, sprue, other inflammatory boweldisease or has a positive test for celiac disease on screening lab and has not had afull investigation performed to exclude celiac disease.

  4. The patient has had unexplained anorexia or weight loss of more than 10% of bodyweight within 12 months of onset of study.

  5. Prior GI surgery except of uncomplicated appendectomy and laparoscopic cholecystectomyor history of bowel obstruction or symptoms suggestive of such within the past 2years.

  6. The patient reports daily use of laxatives or stool softeners; use of fibersupplementation is permitted.

  7. The patient is currently using pancrealipase. Previous use of pancrealipase in thepast is allowed, but patients must be off either of the medication for at least 1 weekor until the patient's symptoms of post prandial diarrhea returns before participatingin the study.

  8. Use of implanted or ambulatory electromechanical medical devices such as pacemakers,insulin pumps, and infusion pumps.

  9. History of gastroparesis or chronic use of reglan.

  10. Dysphagia to solid food and pills.

  11. Previous gastro-esophageal surgery including vagotomy, fundoplication, gastric bypassor ulcer surgery.

  12. Tobacco use within eight hours prior to capsule ingestion and during the 8 hourmonitoring time.

  13. Alcohol use within 24 hours prior to capsule ingestion and throughout the entiremonitoring period (up to 72 hours).

  14. BMI > 35

  15. Female of childbearing age who is not practicing birth control and/or is pregnant orlactating. (Confirm with urine pregnancy test).

Study Design

Study Start date:
April 01, 2010
Estimated Completion Date:
January 31, 2011

Study 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.

Connect with a study center

  • Dr. Mary E. Money

    Hagerstown, Maryland 21740
    United States

    Site Not Available

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