Impact of Propionic Acid on Regulatory T Cell Function in Children With CKD
Recruiting · NCT05858437 · Interventional (participants receive a specific treatment) · Lead sponsor: Charite University, Berlin, Germany
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboSodium propionate
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.
Who can take part
Age range
12 Years to 20 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Department of Pediatric Gastroenterology, Nephrology and Metabolic Diseases, Charité-Universitätsmedizin Berlin - Berlin, Germany