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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment through the post end of treatment follow-up at 16 weeks.

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.