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Impact of Propionic Acid on Regulatory T Cell Function in Children With CKD
Sponsor: Charite University, Berlin, Germany
Summary
Pro-Kids is a multi-center, double-blind, randomized and placebo-controlled intervention study in children with chronic kidney disease. The investigators address the effect of a dietary food supplementation of propionic acid on the immune system and the function of the intestinal barrier in CKD patients treated with hemodialysis.
Official title: Impact of Propionic Acid on Regulatory T Cell Function in Children With Chronic Kidney Disease
Key Details
Gender
All
Age Range
12 Years - 20 Years
Study Type
INTERVENTIONAL
Enrollment
16
Start Date
2024-01-15
Completion Date
2026-04
Last Updated
2025-02-18
Healthy Volunteers
No
Conditions
Interventions
Sodium propionate
The patients will be randomized to PA or placebo intervention (2:1 randomization). After the intervention of 28 days, we conduct an open-label study phase, where all patients are offered a dietary supplement of PA for overall 12 weeks (8 additional weeks for the intervention group and 12 weeks for the placebo group). By doing so we are giving every patient the opportunity to take PA and benefit from the possible positive impact on immunsystem and intestinal barrier function.
Placebo
The patients will be randomized to PA or placebo intervention (2:1 randomization). After the intervention of 28 days, we conduct an open-label study phase, where all patients are offered a dietary supplement of PA for overall 12 weeks (8 additional weeks for the intervention group and 12 weeks for the placebo group). By doing so we are giving every patient the opportunity to take PA and benefit from the possible positive impact on immunsystem and intestinal barrier function.
Locations (1)
Department of Pediatric Gastroenterology, Nephrology and Metabolic Diseases, Charité-Universitätsmedizin Berlin
Berlin, Germany