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First received: October 30, 2023

Clinical Trial: Pilot Study of a New Medical Food in the Management of Ulcerative Colitis

Study Status: NOT_YET_RECRUITING

Recruit Status: NOT_YET_RECRUITING

Condition: Ulcerative Colitis

Study Type: INTERVENTIONAL


Official Title: Development of a Soluble Protein Hydrolysate (SPHi) as a Medical Food for the Treatment of Ulcerative Colitis

Brief Summary: The goal of this clinical trial is to determine at how well a new medical food works in managing inflammation associated with ulcerative colitis in children.The main question it aims to answer is:1) How well does the new medical food lower an inflammatory biomarker known as fecal calprotectin (fCal) in ulcerative colitis as compared to the historical active therapy levels of fCal?Participants will take a specified dose of the medical food in water each day for 12 weeks.The level of fCal will be measured through a…

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