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Probiotic and Prebiotic Supplementation in Peritoneal Dialysis Patients

RecruitingNAAges 18 Years - anyAllHospital Universitario Dr. Jose E. Gonzalez
NCT07694791 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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).
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What it tests

  • Synbiotic
  • Placebo
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Where

1 site
Hospital Universitario Dr. José E. González, Centro Regional de Enfermedades Renales (CRER)
Monterrey, Mexico
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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