RecruitingNot ApplicableNCT07461233

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


Sponsor

Tungs' Taichung Metroharbour Hospital

Enrollment

30 participants

Start Date

May 4, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • Adults aged 18 years or older receiving maintenance hemodialysis patients for at least 3 months

Exclusion Criteria5

  • Use of probiotic supplements within the last month;
  • Hospitalization within the past month for acute infections or CKD-related complications;
  • History of major intestinal surgeries (gastrectomy, cholecystectomy; appendectomy allowed);
  • Presence of viral hepatitis, liver cirrhosis, active malignancy, advanced congestive heart failure, or thyroid disorders;
  • Use of antibiotics or immunosuppressive therapy within the preceding three months.

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Interventions

DIETARY_SUPPLEMENTMultispecies Synbiotic Supplementation

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.


Locations(1)

Tungs' Taichung Metroharbour Hospital

Taichung, Wuqi District, Taiwan

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NCT07461233


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