Impact of Propionic Acid on Regulatory T Cell Function in Children With CKD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-20
SponsorCharite University, Berlin, Germany
About this trial
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
Qualifiers
Body weight: > 30kg
CKD G5 treated with hemodialysis
Continuous hemodialysis treatment for > 3 months
Clinical stable condition
Disqualifiers
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
Trial design
Treatments tested in this trial
- Sodium propionate
- Placebo
Treatment groups
16 Participants
are divided into 2 treatment groupsSponsors and collaborators
Charite University, Berlin, Germany
Lead sponsor
University Hospital Heidelberg
Collaborator
University Hospital, Essen
Collaborator
University Hospital of Cologne
Collaborator
Universitätsklinikum Hamburg-Eppendorf
Collaborator
Source ClinicalTrials.gov