Effect of Propionic Acid on Immune Function in Children with Severe Kidney Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the impact of dietary supplementation with propionic acid on the immune system and intestinal barrier function in children with stage 5 chronic kidney disease (CKD) undergoing hemodialysis. It is a multi-center, double-blind, randomized, and placebo-controlled intervention aimed at normalizing serum levels of propionic acid to reduce chronic inflammation, which is a significant risk factor for cardiovascular disease in CKD patients. The study will assess the function and abundance of regulatory T cells in response to propionic acid supplementation over a defined period.

Why it matters

Who can join: the full rules

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

Where it's running

• Department of Pediatric Gastroenterology, Nephrology and Metabolic Diseases, Charité-Universitätsmedizin Berlin
  Berlin, State of Berlin, Germany Recruiting

Study contacts

• Study coordinator: Johannes Holle, Dr. med.
• Email: johannes-benjamin.holle@charite.de
• Phone: 004930450516012

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.