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Impact of Propionic Acid on Regulatory T Cell Function in Children With Chronic Kidney Disease
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.
Chronic inflammation is a major risk factor of cardiovascular disease progression in CKD, irrespective of confounding comorbidities. Based on current knowledge, microbially-derived metabolites such as short chain fatty acids (SCFA) play an important role in the regulation of chronic inflammatory processes in CKD patients. Children with CKD are known to have reduced serum levels of the SCFA propionic acid (PA), as a consequence of both gut microbial dysbiosis and reduced fiber intake. In animal and human studies the impact of PA on function and abundance of regulatory T cells (Treg) has been demonstrated. Consequently, the investigators aim to normalize the PA serum levels by oral PA food supplementation in hemodialysis patients in order to mitigate chronic inflammation.
Age
12 - 20 years
Sex
ALL
Healthy Volunteers
No
Department of Pediatric Gastroenterology, Nephrology and Metabolic Diseases, Charité-Universitätsmedizin Berlin
Berlin, Germany
Start Date
January 15, 2024
Primary Completion Date
September 1, 2025
Completion Date
April 1, 2026
Last Updated
February 18, 2025
16
ESTIMATED participants
Sodium propionate
DIETARY_SUPPLEMENT
Placebo
OTHER
Lead Sponsor
Charite University, Berlin, Germany
Collaborators
Data Source & Attribution
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