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

NCT06116643 | Unknown Phase 1

• 1 other identifier: IRB-72442
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Fecal Calprotectin Levels

  Level of fecal calprotectin in stool sample at each study visit and compared to historical active therapy fecal calprotectin levels.

  Enrollment through the post end of treatment follow-up at 16 weeks.

Study Arms (1)

Standard Active Therapy plus SPHi

EXPERIMENTAL

Participants will undergo the standard active therapy of ulcerative colitis plus the addition of the ProGo medical food.

Dietary Supplement: Soluble protein hydrolysate (SPHi)

Interventions

Soluble protein hydrolysate (SPHi) DIETARY_SUPPLEMENT

Participants that are already on stable maintenance therapy for ulcerative colitis will continue with their therapy regimen and the addition of 10g of SPHi in 100ml of water every day for 12 weeks.

Standard Active Therapy plus SPHi

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Packard Children's Hospital and Clinics

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Karl Sylvester, MD

CONTACT

650-723-6439; karls@stanford.edu

Elena Harnish, MA

CONTACT

650-723-6439; eharnish@stanford.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-University Med Line

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 3, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 3, 2023

Record last verified: 2023-10

Locations

US (1)