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About
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:
Full 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.
Enrollment
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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.
Primary purpose
Allocation
Interventional model
Masking
25 participants in 1 patient group
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Central trial contact
Karl Sylvester, MD; Elena Harnish, MA
Data sourced from clinicaltrials.gov
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