Study of Propionic Acid Supplement Effects on Immune and Gut Health in Children and Teens with Chronic Kidney Disease on Hemodialysis

What this Trial Is About

Researchers are evaluating the effect of propionic acid, a dietary supplement, on the immune system and intestinal barrier function in children with chronic kidney disease CKD who are treated with hemodialysis. The study focuses on reducing chronic inflammation, a key factor in cardiovascular disease progression in CKD patients, by normalizing low serum levels of propionic acid found in these children due to gut microbial imbalance and low fiber intake. Participants will be randomly assigned to receive either propionic acid capsules or a placebo twice daily for 28 days. After this period, all participants will have the opportunity to take the propionic acid supplement in an open-label phase lasting a total of 12 weeks. The study is double-blind and placebo-controlled to assess the impact of the supplement on regulatory T cell function and inflammation. During the study, participants will undergo various assessments including blood tests to measure regulatory T cells and propionic acid levels, immune cell analysis, intestinal barrier function tests, fecal microbiome analysis, and cardiovascular evaluations at multiple time points over 12 weeks. The primary outcome is the change in regulatory T cell count from the start to week 4. Safety and other health markers will be monitored throughout the study.

Impact of Propionic Acid on Regulatory T Cell Function in Children With CKD