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

NARecruitingINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

January 15, 2024

Primary Completion Date

September 30, 2025

Study Completion Date

April 30, 2026

Conditions
CKD (Chronic Kidney Disease) Stage 5D
Interventions
DIETARY_SUPPLEMENT

Sodium propionate

"The patients will be randomized to PA or placebo intervention (2:1 randomization).~After the intervention of 28 days, we conduct an open-label study phase, where all patients are offered a dietary supplement of PA for overall 12 weeks (8 additional weeks for the intervention group and 12 weeks for the placebo group).~By doing so we are giving every patient the opportunity to take PA and benefit from the possible positive impact on immunsystem and intestinal barrier function."

OTHER

Placebo

"The patients will be randomized to PA or placebo intervention (2:1 randomization).~After the intervention of 28 days, we conduct an open-label study phase, where all patients are offered a dietary supplement of PA for overall 12 weeks (8 additional weeks for the intervention group and 12 weeks for the placebo group).~By doing so we are giving every patient the opportunity to take PA and benefit from the possible positive impact on immunsystem and intestinal barrier function."

Trial Locations (1)

13353

RECRUITING

Department of Pediatric Gastroenterology, Nephrology and Metabolic Diseases, Charité-Universitätsmedizin Berlin, Berlin

All Listed Sponsors
collaborator

University Hospital Heidelberg

OTHER

collaborator

University Hospital, Essen

OTHER

collaborator

University Hospital of Cologne

OTHER

collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

lead

Charite University, Berlin, Germany

OTHER