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

Phase 1

Not yet recruiting

• Conditions: Ulcerative Colitis
• Interventions: Dietary Supplement: Soluble protein hydrolysate (SPHi)

• Registration Number: NCT06116643
• Lead Sponsor: Stanford University

Brief 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.

Detailed Description

The objective of this clinical trial is to assess the physiological response to a biologic food substance in maintenance therapy for ulcerative colitis in children. This will be measured through the measurement of fecal calprotectin (fCal) levels across the study period as well as in comparison to historical active therapy levels. Secondary endpoints will include a variety of biologic markers (inflammatory, microbial, metabolic) as well as clinical scores including patient reported outcomes and serum-based biomarkers such as ferritin and hemoglobin. The aim is to evaluate the effectiveness of the medical food as a safe and well-tolerated non-pharmacologic approach for reducing dependence on drug therapies and their associated side effects in the treatment of ulcerative colitis.

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-30
• Study First Submitted QC: 2023-10-30
• Last Update Submitted: 2023-10-30
• Study First Posted: 2023-11-03
• Last Update Posted: 2023-11-03
• Study Start: 2023-12
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Pediatric patients with a confirmed diagnosis of ulcerative colitis on stable maintenance therapy.

Exclusion Criteria

Pediatric patients with a confirmed diagnosis of ulcerative colitis who utilize oral or topical corticosteroids in maintenance therapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard Active Therapy plus SPHi	Soluble protein hydrolysate (SPHi)	Participants will undergo the standard active therapy of ulcerative colitis plus the addition of the ProGo medical food.

Primary Outcome Measures

Name	Time	Method
Fecal Calprotectin Levels	Enrollment through the post end of treatment follow-up at 16 weeks.	Level of fecal calprotectin in stool sample at each study visit and compared to historical active therapy fecal calprotectin levels.

Trial Locations

Locations (1)

Lucile Packard Children's Hospital and Clinics; 🇺🇸 Palo Alto, California, United States