Medical Food (SPHi) for Ulcerative Colitis

Recruiting in Palo Alto (17 mi)

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Stanford University

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for children with confirmed ulcerative colitis who are on a stable maintenance therapy but not using oral or topical corticosteroids. It's designed to see if a new medical food can manage their condition.

Inclusion Criteria

My child has ulcerative colitis and is on a stable treatment plan.

Exclusion Criteria

I am a child with ulcerative colitis and use steroids for ongoing treatment.

Participant Groups

The study tests how well the Soluble Protein Hydrolysate (SPHi) medical food reduces inflammation in pediatric ulcerative colitis patients by lowering fecal calprotectin levels over a period of 16 weeks.

1Treatment groups

Experimental Treatment

Group I: Standard Active Therapy plus SPHiExperimental Treatment1 Intervention

Participants will undergo the standard active therapy of ulcerative colitis plus the addition of the ProGo medical food.