Impact of Propionic Acid on Regulatory T Cell Function in Children With CKD
Trial Parameters
Eligibility Fast-Check
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Brief 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.
Eligibility Criteria
Inclusion Criteria: * Body weight: \> 30kg * CKD G5 treated with hemodialysis * Continuous hemodialysis treatment for \> 3 months * Clinical stable condition * Manifestation of CKD within childhood (\<18 years) Exclusion Criteria: * Disease or dysfunctions, which disqualifies the patient * Incapacity of contract or any other circumstances, which prohibit the patient or his legal guardians from understanding setup, meaning and entity of the study * Acute infections * Immunosuppressive therapy within the last 12 weeks before the start of the study * Pre-/pro- or postbiotic or antibiotic therapy within the last 4 weeks before the start of the study * Planned or unplanned hospitalization within in last 4 weeks before the start of the study or during study * Malignant diseases * Pregnancy * chronic gastrointestinal or hepatic diseases (for example chronic inflammatory bowel disease * alcohol- or drug abuse * parallel participation on other interventional trials