Effect of Propionic Acid on Immune Function in Children with Severe Kidney Disease
Impact of Propionic Acid on Regulatory T Cell Function in Children With Chronic Kidney Disease
NA · Charite University, Berlin, Germany · NCT05858437
This study is testing if adding propionic acid to the diets of children with severe kidney disease can help improve their immune system and gut health while they are on hemodialysis.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 12 Years to 20 Years |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany (other) |
| Locations | 1 site (Berlin) |
| Trial ID | NCT05858437 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of dietary supplementation with propionic acid on the immune system and intestinal barrier function in children with stage 5 chronic kidney disease (CKD) undergoing hemodialysis. It is a multi-center, double-blind, randomized, and placebo-controlled intervention aimed at normalizing serum levels of propionic acid to reduce chronic inflammation, which is a significant risk factor for cardiovascular disease in CKD patients. The study will assess the function and abundance of regulatory T cells in response to propionic acid supplementation over a defined period.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged under 18 years with stage 5 CKD who have been on hemodialysis for more than three months.
Not a fit: Patients with acute infections, malignancies, or those on immunosuppressive therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could improve immune function and reduce inflammation in children with CKD, potentially leading to better health outcomes.
How similar studies have performed: While the specific approach of using propionic acid supplementation in this context is novel, previous studies have shown positive effects of short-chain fatty acids on immune regulation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Berlin
- Department of Pediatric Gastroenterology, Nephrology and Metabolic Diseases, Charité-Universitätsmedizin Berlin — Berlin, Germany (RECRUITING)
Study contacts
- Study coordinator: Johannes Holle, Dr. med.
- Email: johannes-benjamin.holle@charite.de
- Phone: 004930450516012
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: CKD Stage 5D