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The purpose of this study is to compare the effectiveness and side effects, if any, of BLI800 against NuLYTELY®, a bowel preparation that is approved for pediatric use prior to colonoscopy. BLI800 is already approved by the FDA for adult use, and this study is determining appropriate dosing for adolescents. BLI800 may be easier for patients because it requires less prep solution than the current standard of care.
Subject to certain exclusion criteria, boys and girls aged 12 to 16 years, who are being scheduled to undergo a colonoscopy, are eligible.
Boys and Girls: 12 to 16 years
Prior to colonoscopy, participants will be assigned to take either BLI800 or NuLYTELY for their bowel preparation. For those participants taking the study drug, BLI800 will be provided for consumption the evening before the scheduled colonoscopy at either the full adult dose (6 ounces) or ¾ the adult dose (4.5 ounces). On the morning of the colonoscopy, a second dose of the study medication may be required at least 3 hours before the procedure. Following colonoscopy, participants will return twice, and possibly a third time, for visits that will include a physical examination, blood and urine sample collection.
Visits: Up to 5
Duration: Up to 32 days
Study Description at National Institutes of Health
Dale King, MD
For more information about the study or enrollment, please contact:
Kathleen Calabro RN, BSN
Children's Hospital's main campus is located in the Lawrenceville neighborhood. Our main hospital address is:
Children’s Hospital of Pittsburgh of UPMC
One Children’s Hospital Way
4401 Penn Ave.
Pittsburgh, PA 15224
In addition to the main hospital, Children's has many convenient locations in other neighborhoods throughout the greater Pittsburgh region.
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