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

Sponsor

Stanford University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06116643

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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:

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.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis	Dietary Supplement: Soluble protein hydrolysate (SPHi)	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Development of a Soluble Protein Hydrolysate (SPHi) as a Medical Food for the Treatment of Ulcerative Colitis

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Standard Active Therapy plus SPHi Participants will undergo the standard active therapy of ulcerative colitis plus the addition of the ProGo medical food.	Dietary Supplement: 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.

Arm

Intervention/Treatment

Experimental: Standard Active Therapy plus SPHi

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

Dietary Supplement: 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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lucile Packard Children's Hospital and Clinics	Palo Alto	California	United States	94304

Sponsors and Collaborators

Stanford University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Karl Sylvester, Professor-University Med Line, Stanford University

ClinicalTrials.gov Identifier:

NCT06116643

Other Study ID Numbers:

IRB-72442

First Posted:

Nov 3, 2023

Last Update Posted:

Nov 3, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Colitis

Colitis, Ulcerative

Ulcer

Study Results

No Results Posted as of Nov 3, 2023