Actively Recruiting
Impact of Propionic Acid on Regulatory T Cell Function in Children With Chronic Kidney Disease
Led by Charite University, Berlin, Germany · Updated on 2025-02-18
16
Participants Needed
1
Research Sites
30 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
Researchers are evaluating the effect of propionic acid, a dietary supplement, on the immune system and intestinal barrier function in children with chronic kidney disease (CKD) who are treated with hemodialysis. The study focuses on reducing chronic inflammation, a key factor in cardiovascular disease progression in CKD patients, by normalizing low serum levels of propionic acid found in these children due to gut microbial imbalance and low fiber intake. Participants will be randomly assigned to receive either propionic acid capsules or a placebo twice daily for 28 days. After this period, all participants will have the opportunity to take the propionic acid supplement in an open-label phase lasting a total of 12 weeks. The study is double-blind and placebo-controlled to assess the impact of the supplement on regulatory T cell function and inflammation. During the study, participants will undergo various assessments including blood tests to measure regulatory T cells and propionic acid levels, immune cell analysis, intestinal barrier function tests, fecal microbiome analysis, and cardiovascular evaluations at multiple time points over 12 weeks. The primary outcome is the change in regulatory T cell count from the start to week 4. Safety and other health markers will be monitored throughout the study.
CONDITIONS
Brief 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
- Chronic kidney disease stage 5 treated with hemodialysis
- Continuous hemodialysis treatment for more than 3 months
- Clinically stable condition
- Chronic kidney disease onset before 18 years of age
You will not qualify if you...
- Any disease or dysfunction that disqualifies the patient
- Inability to understand the study due to incapacity or other circumstances
- Acute infections
- Immunosuppressive therapy within 12 weeks before study start
- Use of pre-/pro-/postbiotics or antibiotics 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days
Participants take sodium propionate or placebo capsules twice daily for 28 days to evaluate the impact on regulatory T cell function.
Visits at baseline (week 0), week 2, and week 4
Duration - Up to 12 weeks
All participants are offered an open-label dietary supplement of sodium propionate for up to 12 weeks to assess longer-term effects.
Visits at week 4 and week 12
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.
N
Nicola Wilck, Dr. med.
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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