NCT05858437 Impact of Propionic Acid on Regulatory T Cell Function in Children With CKD
| NCT ID | NCT05858437 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Charite University, Berlin, Germany |
| Condition | CKD (Chronic Kidney Disease) Stage 5D |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2024-01-15 |
| Primary Completion | 2025-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 16 participants in total. It began in 2024-01-15 with a primary completion date of 2025-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05858437 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 20 Years, studying CKD (Chronic Kidney Disease) Stage 5D. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05858437 currently recruiting?
Yes, NCT05858437 is actively recruiting participants. Contact the research team at johannes-benjamin.holle@charite.de for enrollment information.
Where is the NCT05858437 trial being conducted?
This trial is being conducted at Berlin, Germany.
Who is sponsoring the NCT05858437 clinical trial?
NCT05858437 is sponsored by Charite University, Berlin, Germany. The trial plans to enroll 16 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.