Conditions: Pill Capsule Endoscopy Completion Rates
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 5
Healthy volunteers: no

Brief summary:
Patients undergoing small bowel capsule endoscopy will be randomized into 3 study groups to either receive 5 mg of metoclopramide, 10 mg of metoclopramide, or a placebo 30 minutes prior to swallowing the Pill Cam. This is a randomized, double-blind, placebo-controlled design. The outcomes to be assessed are capsule study completion rates, gastric transit time, small bowel transit time, and the effect of diabetes on pill capsule completion rates. The purpose of the study is to assess if metoclopramide given prior to pill capsule endoscopy has any effect on pill capsule completion rate, gastric transit time, small bowel transit time, and pill capsule completion rates in diabetes.

Detailed description:
Pill Capsule Endoscopy allows Gastroenterologists to visualize the mucosa of the small bowel beyond the reach of any endoscope and to an extent never before possible. It involves the ingestion of a small pill camera approximately the size of a large vitamin. 8 hours of images are transmitted to a sensor worn around the patient's waist. At the conclusion of the test, these images are downloaded to a computer for physician review. Meanwhile, the PillCam™ passes naturally through the digestive system and does not require retrieval.

Many of these pill capsule studies are incomplete due to failure of the pill capsule to reach the colon. Metoclopramide (brand name Reglan) is an anti-emetic that also has known pro-motility effects in the GI tract. The thought behind this study is that metoclopramide will increase the rate of passage of the pill capsule through the GI tract allowing a higher completion rate of the pill capsule studies.

Patients scheduled for pill capsule endoscopy will be approached on the morning of their procedure to inform them of the research study. After proper consent is obtained the patient will receive either 5 mg Metoclopramide, 10 mg Metoclopramide, or a placebo pill 30 minutes prior to their pill capsule study. The pill capsule camera records 8 hours worth of data. The patient will return at the conclusion of their study to turn in their recorder. The ordering gastroenterologist will then read the study. Information regarding pill capsule completion (pill capsule goes through the ileocecal valve), gastric transit time, and small bowel transit time will then be recorded and analyzed.

Arms:
arm 1: Pro-motility agent arm 2: Pro-motility agent arm 3: Placebo to be used as the control group

Interventions: intervention 1: Metoclopramide intervention 2: Placebo
Intervention descriptions: intervention 1: A one time dose of either Metoclopramide 5 mg or 10 mg (or placebo) given orally 30 minutes prior to pill capsule endoscopy. intervention 2: A placebo capsule made to look like the metoclopramide capsule.

Protocol document: