Impact of Propionic Acid on Regulatory T Cell Function in Children With CKD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-20
SponsorCharite University, Berlin, Germany
About this trial
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
This trial does not accept healthy volunteersQualifiers
Body weight: > 30kg
CKD G5 treated with hemodialysis
Continuous hemodialysis treatment for > 3 months
Clinical stable condition
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Sodium propionate
Dietary supplementThe patients will be randomized to PA or placebo intervention (2:1 randomization). After the intervention of 28 days, we conduct an open-label study phase, where all patients are offered a dietary supplement of PA for overall 12 weeks (8 additional weeks for the intervention group and 12 weeks for the placebo group). By doing so we are giving every patient the opportunity to take PA and benefit from the possible positive impact on immunsystem and intestinal barrier function.
Placebo
Other interventionThe patients will be randomized to PA or placebo intervention (2:1 randomization). After the intervention of 28 days, we conduct an open-label study phase, where all patients are offered a dietary supplement of PA for overall 12 weeks (8 additional weeks for the intervention group and 12 weeks for the placebo group). By doing so we are giving every patient the opportunity to take PA and benefit from the possible positive impact on immunsystem and intestinal barrier function.
Treatment groups
16 Participants
are divided into 2 treatment groupsGroup A: PA InterventionExperimental treatment 1 intervention
Group B: Placebo InterventionPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in count of regulatory T-cells from baseline to week 4
Analysis of Treg counts in whole blood (absolute quantification) and peripheral blood mononuclear cells (PBMC; relative quantification) by flow cytometry.
Time frame
Baseline visit (week 0) in comparison to week 4Secondary outcomes
1
Propionic acid serum levels and targeted metabolomics
Analysis of PA serum levels and other microbially-derived metabolites by GC-MS and LC-MS
Time frame
Baseline visit (week 0); Week 2; Week 4; Week 122
Immune cell phenotyping of peripheral blood mononuclear cells (PBMC)
Patients PBMC will be thawed and immune cells we be analyzed using multicolor flow cytometry and mass cytometry. By using a broad range of different antibodies combined in several panels the investigators will analyse distinct T cell subtypes including markers of activation, but also other immune cells (including B cells, dendritic cells, monocytes, natural killer cells). Data will reported in relation to parent populations (e.g. T heller cells in % of T cells).
Time frame
Baseline visit (week 0); Week 2; Week 4; Week 123
T regulatory cell (Treg) suppression assay
The suppressive capacity of patients Treg will be analyzed by co-cultivation with conventional, stimulated T cells (Tconv) in different proportions (Treg:Tconv). The proliferation of Tconv will be reported.
Time frame
Baseline visit (week 0); Week 44
Single cell RNA sequencing of immune cells
Analysis of the transcriptome of immune cells using cellular indexing of transcriptomes and epitopes (CITEseq)
Time frame
Baseline visit (week 0); Week 4Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Charite University, Berlin, Germany
Lead sponsor
University Hospital Heidelberg
Collaborator
University Hospital, Essen
Collaborator
University Hospital of Cologne
Collaborator
Universitätsklinikum Hamburg-Eppendorf
Collaborator
Source ClinicalTrials.gov