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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,395 Previous Clinical Trials

17,341,430 Total Patients Enrolled

9 Trials studying Ulcerative Colitis

237 Patients Enrolled for Ulcerative Colitis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Standard Active Therapy plus SPHi?

"The level of safety related to the Standard Active Therapy plus SPHi combination is rated at 1 on our scale due to the limited data available from this Phase 1 trial."

Answered by AI

Who is eligible to join this investigation?

"This specific trial is looking to recruit 25 patients with ulcerative colitis between the ages of 7 and 18."

Answered by AI

Does this trial accept applicants aged 75 or above?

"According to the terms of eligibility, only those aged 7-18 are suitable for this trial. For younger patients, there are 80 available clinical trials and 368 studies open to participants over 65 years old."

Answered by AI

Are new participants being enrolled in this experiment currently?

"According to clinicaltrials.gov, the current status of this trial is not recruiting, with its initial posting on December 1st 2023 and last update being October 30th 2023. Nonetheless, there are over 400 other trials actively seeking participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Karl Sylvester 2023. "Pilot Study of a New Medical Food in the Management of Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06116643.