Actively Recruiting
Impact of Propionic Acid on Regulatory T Cell Function in Children With CKD
Led by Charite University, Berlin, Germany · Updated on 2025-02-18
16
Participants Needed
1
Research Sites
115 weeks
Total Duration
On this page
Sponsors
C
Charite University, Berlin, Germany
Lead Sponsor
U
University Hospital Heidelberg
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Impact of Propionic Acid on Regulatory T Cell Function in Children With CKD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body weight greater than 30 kilograms
- Diagnosed with chronic kidney disease stage 5 treated with hemodialysis
- Receiving continuous hemodialysis treatment for more than 3 months
- Clinically stable condition
- Chronic kidney disease developed before age 18 years
You will not qualify if you...
- Any disease or condition that disqualifies the patient
- Inability to understand the study due to incapacity or other reasons
- Presence of acute infections
- Immunosuppressive therapy within 12 weeks before study start
- Use of prebiotic, probiotic, postbiotic, or antibiotic therapy within 4 weeks before study start
- Planned or unplanned hospitalization within 4 weeks before or during the study
- Malignant diseases
- Pregnancy
- Chronic gastrointestinal or liver diseases such as inflammatory bowel disease
- Alcohol or drug abuse
- Participation in other interventional clinical trials concurrently
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Pediatric Gastroenterology, Nephrology and Metabolic Diseases, Charité-Universitätsmedizin Berlin
Berlin, Germany, 13353
Actively Recruiting
Research Team
J
Johannes Holle, Dr. med.
CONTACT
N
Nicola Wilck, Dr. med.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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