Impact of Propionic Acid on Regulatory T Cell Function in Children With CKD

NCT05858437 | Recruiting

• 1 other identifier: EA2/195/22
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

CKD (Chronic Kidney Disease) Stage 5D

Outcome Measures

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.

  Baseline visit (week 0) in comparison to week 4

Secondary Outcomes (9)

• Propionic acid serum levels and targeted metabolomics

  Baseline visit (week 0); Week 2; Week 4; Week 12

• Immune cell phenotyping of peripheral blood mononuclear cells (PBMC)

  Baseline visit (week 0); Week 2; Week 4; Week 12

• T regulatory cell (Treg) suppression assay

  Baseline visit (week 0); Week 4

• Single cell RNA sequencing of immune cells

  Baseline visit (week 0); Week 4

• Intestinal barrier function

  Baseline visit (week 0); Week 2; Week 4; Week 12

Study Arms (2)

PA Intervention

EXPERIMENTAL

The group which receives the PA as a dietary food supplement. A single capsule contains 500mg of sodiumpropionate, which is taken twice daily for 28 days.

Dietary Supplement: Sodium propionate

Placebo Intervention

PLACEBO COMPARATOR

The control-group receives a placebo instead of propionate. The placebo contains maltodextrin and the same amount of sodium chloride as compared to the PA intervention. The placebo is taken twice per day for 28 days.

Other: Placebo

Interventions

Sodium propionate DIETARY_SUPPLEMENT

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.

PA Intervention

Placebo OTHER

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.

Placebo Intervention

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Body weight: \> 30kg
• CKD G5 treated with hemodialysis
• Continuous hemodialysis treatment for \> 3 months
• Clinical stable condition
• Manifestation of CKD within childhood (\<18 years)

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• University Hospital Heidelberg: collaborator
• University Hospital, Essen: collaborator
• University Hospital of Cologne: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator

Study Sites (1)

Department of Pediatric Gastroenterology, Nephrology and Metabolic Diseases, Charité-Universitätsmedizin Berlin

Berlin, 13353, Germany

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

sodium propionate

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Johannes Holle, Dr. med.

CONTACT

004930450516012; johannes-benjamin.holle@charite.de

Nicola Wilck, Dr. med.

CONTACT

004930450516012; nicola.wilck@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized, double-blind, placebo-controlled

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 15, 2023
• Study Start: January 15, 2024
• Primary Completion: September 1, 2025
• Study Completion: April 1, 2026
• Last Updated: February 18, 2025

Record last verified: 2025-02

Locations

DE (1)