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NCT06116643Not yet recruiting

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

Development of a Soluble Protein Hydrolysate (SPHi) as a Medical Food for the Treatment of Ulcerative Colitis
Stanford UniversityPhase 1ClinicalTrials.govdietary supplement
Verified
Study focus
Disease/Condition
Ulcerative Colitis
Drug/Device/Intervention
Soluble protein hydrolysate (SPHi)
Study type
Interventional
Intervention type
dietary supplement
Sponsor & location
Primary sponsor
Stanford University
Location
Palo Alto, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Dec 01, 2023
End date
Dec 01, 2025
Enrollment
25 participants
Primary outcome

Fecal Calprotectin Levels

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 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.

ICD-10 classifications
Ulcerative colitisOther ulcerative colitisUlcerative colitis, unspecifiedArthropathy in ulcerative colitisJuvenile arthritis in ulcerative colitis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06116643
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06116643 through Pure Global AI's free database. This Phase 1 trial is sponsored by Stanford University and is currently Not yet recruiting. The study focuses on Ulcerative Colitis. Target enrollment is 25 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.