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Lack of interest in participation by patients locally and lack of funding.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| non-trigger meal | Active Comparator | Measurement of intestinal transport eating a "non-trigger meal". |
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| "trigger meal baseline" | Active Comparator | Measurement of intestinal transport after eating a "trigger meal". |
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| "trigger meal" with placebo | Placebo Comparator | Measurement of intestinal transport with blinded placebo |
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| "trigger meal" with enzymes (blinded) | Active Comparator | Measurement of intestinal transport with blinded active enzyme capsule |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pancelipase/placebo | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of intestinal speed of a "trigger meal" compared to a non-trigger meal baseline. Optional study comparing intestinal speed of trigger meal using Pancrelipase compared to placebo. | Data from the SmartPill radiofrequency capsule that is swallowed at the beginning of the different meals will be recorded and compared. | 72 hour measurement per meal |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary E Money, M.D. | Washington County Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19238028 | Background | Money ME, Hofmann AF, Hagey LR, Walkowiak J, Talley NJ. Treatment of irritable bowel syndrome-diarrhea with pancrealipase or colesevelam and association with steatorrhea. Pancreas. 2009 Mar;38(2):232-3. doi: 10.1097/MPA.0b013e31817c1b36. No abstract available. |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| SmartPill capsule | Device | Measurement of a baseline, non-trigger meal intestinal transit by using the SmartPill capsule. |
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| SmartPill capsule | Device | Measurement of intestinal transit of a "trigger meal" baseline by using the SmartPill capsule |
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| SmartPill capsule | Device | SmartPill capsule |
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| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |