Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Probiotic and Prebiotic Supplementation in Peritoneal Dialysis Patients

4 juli 2026 uppdaterad 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

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

60

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

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

Studera Kontakt Backup

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

Studieorter

  • Mexiko
    • Nuevo León
      • Monterrey, Nuevo León, Mexiko, 64460
        • Rekrytering
        • Hospital Universitario Dr. José E. González, Centro Regional de Enfermedades Renales (CRER)
        • Kontakt:
        • Kontakt:
          • Heidi Daniela Hernández Francisco, MD
          • Telefonnummer: 528180259573
          • E-post: heididhf@gmail.com
        • Huvudutredare:
          • Elisa María Guadalupe Guerrero González, MD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: Placebo
Participants assigned to this arm will receive one identical, inactive oral capsule daily for a period of 6 months.
Kosttillskott: 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.
Experimentell: 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.
Kosttillskott: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change from baseline in serum high-sensitivity C-reactive protein (hs-CRP) at 3 and 6 months.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change from baseline in Malnutrition-Inflammation Score (MIS) at 3 and 6 months.
Tidsram: 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.
Tidsram: 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.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

3 oktober 2025

Primärt slutförande (Beräknad)

1 juni 2027

Avslutad studie (Beräknad)

1 juni 2027

Studieregistreringsdatum

Först inskickad

4 juli 2026

Först inskickad som uppfyllde QC-kriterierna

4 juli 2026

Första postat (Faktisk)

10 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • NF25-00008

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera