Alterations of Gut Derived Uremic Toxins and Microbiome Metabolites by Multispecies Synbiotic
Recruiting now · Not applicable
Conditions studied: Symbiotic, Uremic Toxins, Gut -Microbiota
In brief
Patients with chronic kidney disease (CKD) undergoing maintenance hemodialysis frequently exhibit significant gut microbiota dysbiosis and increased intestinal permeability. These alterations enable the translocation of endotoxins and gut-derived uremic toxins-such as indoxyl sulfate and p-cresyl sulfate-into the systemic circulation, exacerbating systemic inflammation, elevating cardiovascular risk, and accelerating disease progression. Multispecies synbiotic supplementation has emerged as a promising intervention to restore gut microbial equilibrium, strengthen intestinal barrier function, and reduce the systemic load of harmful microbial metabolites. Through modulation of inflammatory pathways and reduction of circulating uremic toxins, synbiotic hold potential to improve clinical outcomes in this vulnerable population. Although preclinical and some clinical evidence suggests benefits of probiotic therapy, comprehensive clinical trials specifically examining multispecies synbiotic effects on gut inflammatory markers, gut derived metabolite profiles, and uremic toxin levels in hemodialysis patients remain limited. This pilot study aims to address this gap by investigating the biological and clinical effects of a 12-week multispecies regimen in adult maintenance hemodialysis patients.
Key facts
- Study ID
- NCT07443280
- Run by
- Tungs' Taichung Metroharbour Hospital
- People needed
- 30
- Starts
- 2026-05-04
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-06-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults aged 18 years or older receiving maintenance hemodialysis patients for at least 3 months
You may not qualify if…
- 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.
Where it is running
- Tungs' Taichung Metroharbour Hospital — Taichung, Wuqi District, Taiwan (enrolling)
Full record on ClinicalTrials.gov
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