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

Status unconfirmed · Phase 1

Conditions studied: Ulcerative Colitis

In brief

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 stool sample at baseline, one during the 12 weeks, at the end of 12 weeks, and once more at 16 weeks. The levels of fCal will be compared across the 16 weeks and compared with levels before the new medical food was taken.

Key facts

Study ID

NCT06116643

Run by

Stanford University

People needed

25

Starts

2023-12-01

Expected to finish

2025-12-01

Last updated by the study team

2023-11-03

Who can join

Age: 7 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pediatric patients with a confirmed diagnosis of ulcerative colitis on stable maintenance therapy.

You may not qualify if…

• Pediatric patients with a confirmed diagnosis of ulcerative colitis who utilize oral or topical corticosteroids in maintenance therapy.

Where it is running

• Lucile Packard Children's Hospital and Clinics — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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