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Dietary Supplement

Medical Food (SPHi) for Ulcerative Colitis

Phase 1
Waitlist Available
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pediatric patients with a confirmed diagnosis of ulcerative colitis on stable maintenance therapy.
Be younger than 65 years old
Must not have
Pediatric patients with a confirmed diagnosis of ulcerative colitis who utilize oral or topical corticosteroids in maintenance therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrollment through the post end of treatment follow-up at 16 weeks.
Awards & highlights

Summary

This trial examines how well a new medical food can lower inflammation in children with ulcerative colitis by measuring an inflammatory biomarker.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
The description doesn't specify side effects, but as with any new dietary intervention, potential side effects may include gastrointestinal discomfort or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child has ulcerative colitis and is on a stable treatment plan.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am a child with ulcerative colitis and use steroids for ongoing treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment through the post end of treatment follow-up at 16 weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment through the post end of treatment follow-up at 16 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Fecal Calprotectin Levels

Trial Design

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.

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,448 Previous Clinical Trials
17,492,369 Total Patients Enrolled
9 Trials studying Ulcerative Colitis
237 Patients Enrolled for Ulcerative Colitis
~15 spots leftby Dec 2025
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