Impact of Propionic Acid on Regulatory T Cell Function in Children With CKD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sodium propionate, Placebo.
- Who it may be relevant to
- Registry conditions: CKD (Chronic Kidney Disease) Stage 5D. Basic parameters: 12 years — 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Propionic Acid on Regulatory T Cell Function in Children With Chronic Kidney Disease
Overview
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.
Detailed description
Chronic inflammation is a major risk factor of cardiovascular disease progression in CKD, irrespective of confounding comorbidities. Based on current knowledge, microbially-derived metabolites such as short chain fatty acids (SCFA) play an important role in the regulation of chronic inflammatory processes in CKD patients. Children with CKD are known to have reduced serum levels of the SCFA propionic acid (PA), as a consequence of both gut microbial dysbiosis and reduced fiber intake. In animal and human studies the impact of PA on function and abundance of regulatory T cells (Treg) has been demonstrated. Consequently, the investigators aim to normalize the PA serum levels by oral PA food supplementation in hemodialysis patients in order to mitigate chronic inflammation.
Interventions
- Dietary supplement Sodium propionate
The 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. - Other Placebo
The 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.
Primary outcome measures
- Change in count of regulatory T-cells from baseline to week 4 [Time frame: Baseline visit (week 0) in comparison to week 4]
Secondary outcome measures (9)
- Propionic acid serum levels and targeted metabolomics [Time frame: Baseline visit (week 0); Week 2; Week 4; Week 12]
- Immune cell phenotyping of peripheral blood mononuclear cells (PBMC) [Time frame: Baseline visit (week 0); Week 2; Week 4; Week 12]
- T regulatory cell (Treg) suppression assay [Time frame: Baseline visit (week 0); Week 4]
- Single cell RNA sequencing of immune cells [Time frame: Baseline visit (week 0); Week 4]
- Intestinal barrier function [Time frame: Baseline visit (week 0); Week 2; Week 4; Week 12]
- Taxonomy of the fecal microbiome [Time frame: Baseline visit (week 0); Week 4]
- Cardiovascular Phenotyping [Time frame: Baseline visit (week 0); Week 2; Week 4; Week 12]
- Cardiovascular Phenotyping [Time frame: Baseline visit (week 0); Week 2; Week 4; Week 12]
- Cholesterol levels [Time frame: Baseline visit (week 0); Week 2; Week 4; Week 12]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Basic science
Study locations
Germany · 1 center
- Department of Pediatric Gastroenterology, Nephrology and Metabolic Diseases, Charité-Unive — Berlin
Identifiers
NCT: NCT05858437 · EA2/195/22