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

NCT ID: NCT06116643

Last Updated: 2023-11-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-31
• Study Completion Date: 2025-12-31

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.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Active Therapy plus SPHi

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

Group Type: EXPERIMENTAL

Soluble protein hydrolysate (SPHi)

Intervention Type: 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.

Interventions

Soluble protein hydrolysate (SPHi)

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Karl Sylvester

Professor-University Med Line

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lucile Packard Children's Hospital and Clinics

Palo Alto, California, United States

Countries

United States

Central Contacts

Karl Sylvester, MD

Role: CONTACT

karls@stanford.edu

650-723-6439

Elena Harnish, MA

Role: CONTACT

eharnish@stanford.edu

650-723-6439

Facility Contacts

Karl Sylvester, MD

Role: primary

karls@stanford.edu

650-723-6439

Other Identifiers

IRB-72442

Identifier Type: -

Identifier Source: org_study_id