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Probiotic and Prebiotic Supplementation in Peritoneal Dialysis Patients

4. juli 2026 oppdatert av: Irma Isabel Flores Ponzio, Hospital Universitario Dr. Jose E. Gonzalez

Impact of Synbiotic Supplementation in Peritoneal Dialysis Patients

The goal of this clinical trial is to learn if synbiotics work to lower inflammation in adults with chronic kidney disease who are on peritoneal dialysis. Synbiotics are daily capsules that contain a mix of probiotics (good bacteria) and prebiotics (fiber that feeds good bacteria).

The main questions it aims to answer are:

Do synbiotics lower the level of inflammation markers in the blood? Do synbiotics improve the nutritional status of the participants? Do synbiotics lower the number of peritonitis (peritoneal infections) episodes?

Researchers will compare synbiotics to a placebo to see if the treatment works. A placebo is a look-alike capsule that contains no active ingredients. Participants will:

Take 1 capsule every day for 6 months Visit the clinic at the start, at 3 months, and at 6 months for blood tests and nutrition checkups

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a randomized, controlled, double-blind clinical trial designed to evaluate the clinical and biochemical impact of synbiotic supplementation in patients with chronic kidney disease undergoing peritoneal dialysis at the Regional Center for Kidney Diseases. Eligible participants will be randomly assigned in a 1:1 ratio into one of two parallel groups for a 6-month period:

  1. Synbiotic Group: Participants will receive one oral capsule daily in the morning before meals, containing prebiotic fibers (chicory inulin root and tapioca starch) and probiotic strains (Bifidobacterium longum, Lactobacillus acidophilus, and Streptococcus thermophilus) at a concentration of 7.5 x 10^12 CFU/100g.
  2. Placebo Group: Participants will receive one identical, inactive oral capsule daily.

Clinical and biochemical evaluations will be conducted at three distinct time points: Baseline (Visit 1), 3 months (Visit 2), and 6 months (Visit 3). At each visit, blood samples will be drawn to measure primary pro-inflammatory and uremic toxin markers, specifically p-cresol and indoxyl sulfate, alongside high-sensitivity C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR). Additionally, nutritional status will be evaluated using the Malnutrition-Inflammation Score (MIS). Secondary clinical outcomes, including the incidence of peritonitis episodes, will be documented throughout the entire 6-month study duration. To ensure protocol compliance, participant adherence will be tracked using two methods: Pill-counts conducted during each scheduled follow-up visit and periodic telephone calls between visits to provide reminders and monitor supplement intake.

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiekontakt

  • Navn: Elisa María Guadalupe Guerrero González, MD
  • Telefonnummer: 528182803788
  • E-post: eguerrerog@uanl.edu.mx

Studer Kontakt Backup

  • Navn: Giovanna Yazmín Arteaga Müller, MD, PhD
  • Telefonnummer: 528112512168
  • E-post: giomuller@gmail.com

Studiesteder

  • Mexico
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Rekruttering
        • Hospital Universitario Dr. José E. González, Centro Regional de Enfermedades Renales (CRER)
        • Ta kontakt med:
        • Ta kontakt med:
          • Heidi Daniela Hernández Francisco, MD
          • Telefonnummer: 528180259573
          • E-post: heididhf@gmail.com
        • Hovedetterforsker:
          • Elisa María Guadalupe Guerrero González, 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

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Patients aged 18 years or older.
  • Patients diagnosed with kidney disease who have been receiving peritoneal dialysis at home for at least 1 month.

Exclusion Criteria:

  • Patients who are unable to eat or receive food through a feeding tube.
  • Patients who have taken prebiotics or probiotics (supplements that support gut health) in the month before the study starts.
  • Patients who used antibiotics in the month before the study starts.
  • Patients who cannot attend the scheduled follow-up visits (missing the second follow-up appointment will result in being removed from the study).
  • Note on non-adherence and withdrawal: Patients who are unable to take their assigned capsules regularly (taking less than 80% of the total capsules will result in being removed from the study).

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo
Participants assigned to this arm will receive one identical, inactive oral capsule daily for a period of 6 months.
Kosttilskudd: Placebo
Oral administration of one identical, inactive oral capsule daily taken in the morning before meals for a period of 6 months. The placebo capsule looks, tastes, and smells exactly like the intervention supplement but contains no active ingredients.
Eksperimentell: Synbiotic
Participants assigned to this arm will receive one oral capsule daily for a period of 6 months. Each capsule contains a combination of probiotic strains and prebiotic fibers.
Kosttilskudd: Synbiotic
Oral administration of an active nutritional supplement consisting of one capsule daily taken in the morning before meals for 6 months. Each capsule contains a specific synbiotic formulation composed of probiotic strains (Bifidobacterium longum, Lactobacillus acidophilus, and Streptococcus thermophilus at 7.5 x 10^12 CFU/100g) combined with prebiotic soluble fibers (chicory inulin root and tapioca starch) designed to modulate the gut microbiota.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from baseline in serum high-sensitivity C-reactive protein (hs-CRP) at 3 and 6 months.
Tidsramme: Baseline (Month 0), Month 3, and Month 6.
Serum hs-CRP levels will be measured to evaluate systemic inflammation. The change will be assessed by comparing values at 3 and 6 months against the baseline values.
Baseline (Month 0), Month 3, and Month 6.
Change from baseline in Erythrocyte Sedimentation Rate (ESR) at 3 and 6 months.
Tidsramme: Baseline (Month 0), Month 3, and Month 6.
Erythrocyte Sedimentation Rate (ESR) will be measured to evaluate systemic inflammation. The change will be assessed by comparing values at 3 and 6 months against the baseline values.
Baseline (Month 0), Month 3, and Month 6.
Change from baseline in serum p-Cresyl Sulfate (pCS) levels at 3 and 6 months.
Tidsramme: Baseline (Month 0), Month 3, and Month 6.
Serum levels of the microbiota-derived uremic toxin p-Cresyl Sulfate will be quantified to evaluate the effect of the synbiotic intervention over time. The change will be assessed by comparing values at 3 and 6 months against the baseline values.
Baseline (Month 0), Month 3, and Month 6.
Change from baseline in serum Indoxyl Sulfate (IS) levels at 3 and 6 months.
Tidsramme: Baseline (Month 0), Month 3, and Month 6.
Serum levels of Indoxyl Sulfate will be quantified as a key protein-bound uremic toxin to determine if the synbiotic intervention decreases its accumulation. The change will be assessed by comparing values at 3 and 6 months against the baseline values.
Baseline (Month 0), Month 3, and Month 6.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from baseline in Malnutrition-Inflammation Score (MIS) at 3 and 6 months.
Tidsramme: Baseline (Month 0), Month 3, and Month 6.
The Malnutrition-Inflammation Score (MIS) will be used to assess the nutritional and inflammatory status of the patients. The score ranges from 0 (normal) to 30 (severe malnutrition and inflammation), where a higher score indicates a more severe degree of malnutrition. The change will be assessed by comparing values at 3 and 6 months against the baseline values.
Baseline (Month 0), Month 3, and Month 6.
Number of peritonitis episodes during the 6-month follow-up period.
Tidsramme: Up to 6 months.
The total number of confirmed peritonitis episodes per patient will be recorded throughout the study to evaluate if the synbiotic intervention reduces the incidence of infectious complications compared to the placebo group.
Up to 6 months.

Samarbeidspartnere og etterforskere

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

Sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Etterforskere

  • Hovedetterforsker: Elisa María Guadalupe Guerrero González, MD, Hospital Universitario. Dr. José Eleuterio González

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

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)

3. oktober 2025

Primær fullføring (Antatt)

1. juni 2027

Studiet fullført (Antatt)

1. juni 2027

Datoer for studieregistrering

Først innsendt

4. juli 2026

Først innsendt som oppfylte QC-kriteriene

4. juli 2026

Først lagt ut (Faktiske)

10. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NF25-00008

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

To protect the confidentiality of the participants, individual participant data will not be made publicly available.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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