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Effekten av propionsyre på regulatorisk T-cellefunksjon hos barn med CKD (Pro-Kids)

3. november 2026 oppdatert av: Johannes Benjamin Holle, Charite University, Berlin, Germany

Effekten av propionsyre på regulatorisk T-cellefunksjon hos barn med kronisk nyresykdom

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

16

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Tyskland
    • State of Berlin
      • Berlin, State of Berlin, Tyskland, 13353
        • Rekruttering
        • Department of Pediatric Gastroenterology, Nephrology and Metabolic Diseases, Charité-Universitätsmedizin Berlin
        • Ta kontakt med:
          • Johannes Holle, MD
        • Ta kontakt med:
          • Dominik Müller, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

12 år til 20 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: PA Intervention

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.
Kosttilskudd: 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.
Placebo komparator: Placebo Intervention

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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in count of regulatory T-cells from baseline to week 4
Tidsramme: Baseline visit (week 0) in comparison 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Propionic acid serum levels and targeted metabolomics
Tidsramme: Baseline visit (week 0); Week 2; Week 4; Week 12

Analysis of PA serum levels and other microbially-derived metabolites by GC-MS and LC-MS
Baseline visit (week 0); Week 2; Week 4; Week 12
Immune cell phenotyping of peripheral blood mononuclear cells (PBMC)
Tidsramme: Baseline visit (week 0); Week 2; Week 4; Week 12

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).
Baseline visit (week 0); Week 2; Week 4; Week 12
T regulatory cell (Treg) suppression assay
Tidsramme: Baseline visit (week 0); Week 4

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.
Baseline visit (week 0); Week 4
Single cell RNA sequencing of immune cells
Tidsramme: Baseline visit (week 0); Week 4

Analysis of the transcriptome of immune cells using cellular indexing of transcriptomes and epitopes (CITEseq)
Baseline visit (week 0); Week 4
Intestinal barrier function
Tidsramme: Baseline visit (week 0); Week 2; Week 4; Week 12

Analysis of biomarkers for intestinal barrier function, such as sCD14, zonulin-1 and LPS
Baseline visit (week 0); Week 2; Week 4; Week 12
Taxonomy of the fecal microbiome
Tidsramme: Baseline visit (week 0); Week 4

The taxonomy of the fecal microbiome will be anayzed using 16S RNA amplicon sequencing.
Baseline visit (week 0); Week 4
Cardiovascular Phenotyping
Tidsramme: Baseline visit (week 0); Week 2; Week 4; Week 12

Analysis of heart rate over time.
Baseline visit (week 0); Week 2; Week 4; Week 12
Cardiovascular Phenotyping
Tidsramme: Baseline visit (week 0); Week 2; Week 4; Week 12

Analysis of blood pressure over time.
Baseline visit (week 0); Week 2; Week 4; Week 12
Cholesterol levels
Tidsramme: Baseline visit (week 0); Week 2; Week 4; Week 12

Cholesterol levels will be assessed using standard clinical lab values.
Baseline visit (week 0); Week 2; Week 4; Week 12

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Charite University, Berlin, Germany

Samarbeidspartnere

University Hospital, Essen
University Hospital Heidelberg
Universitätsklinikum Hamburg-Eppendorf
University Hospital of Cologne

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. januar 2024

Primær fullføring (Faktiske)

8. juli 2026

Studiet fullført (Antatt)

1. mars 2027

Datoer for studieregistrering

Først innsendt

25. april 2023

Først innsendt som oppfylte QC-kriteriene

4. mai 2023

Først lagt ut (Faktiske)

15. mai 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. november 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • EA2/195/22

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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