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Modulation of Gut Microbiota Composition and Gut Permeability Profiles by Multispecies Synbiotic Supplementation in Hemodialysis Patients

Sponsor: Tungs' Taichung Metroharbour Hospital • ClinicalTrials.gov ID: NCT07461233

Registry updated: 2026-09-25

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Description

Chronic kidney disease (CKD) patients undergoing maintenance hemodialysis experience profound alterations in their gut microbiota, leading to dysbiosis and increased gut permeability. This disruption facilitates the translocation of endotoxins and gut-derived uremic toxins such as indoxyl sulfate and p-cresyl sulfate into the systemic circulation, contributing to heightened systemic inflammation, cardiovascular disease risk, and accelerated CKD progression. Synbiotic supplementation, particularly multispecies formulations, has emerged as a promising therapeutic strategy to restore gut microbial balance, enhance intestinal barrier integrity, and reduce the systemic burden of deleterious microbial metabolites. These probiotics potentially improve clinical outcomes by modulating inflammatory pathways and decreasing circulating levels of uremic toxins. Despite these insights, few clinical trials have comprehensively assessed the effects of multispecies synbiotic on fecal microbiome composition, gut permeability and uremic toxin profiles in hemodialysis patients. This pilot study aims to fill this gap by evaluating the modulatory effects of a 12-week multispecies synbiotic intervention.

Interventions

Multispecies Synbiotic Supplementation (Dietary supplement)
Participants will receive Renobiome multispecies synbiotic containing 30 billion CFUs per capsule, including strains of Lactobacillus rhamnosus (strain ID pending), Lactobacillus salivarius LS 159, Lactobacillus pentosus LPE 588, and Lactococcus lactis LL 358. • Dose: One capsule twice daily (morning and evening), with or without food, taken with room-temperature water. • Storage: Capsules to be kept below 25°C, in a dry, light-protected environment.

Eligibility criteria

Inclusion Criteria: * Adults aged 18 years or older receiving maintenance hemodialysis patients for at least 3 months Exclusion Criteria: 1. Use of probiotic supplements within the last month; 2. Hospitalization within the past month for acute infections or CKD-related complications; 3. History of major intestinal surgeries (gastrectomy, cholecystectomy; appendectomy allowed); 4. Presence of viral hepatitis, liver cirrhosis, active malignancy, advanced congestive heart failure, or thyroid disorders; 5. Use of antibiotics or immunosuppressive therapy within the preceding three months.

Conditions

Symbiotic Uremic Toxins Gut -Microbiota Gut Permeability Hemodialysis

Locations

Tungs' Taichung Metroharbour Hospital — Taichung, Wuqi District, Taiwan

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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