NCT07443280 Alterations of Gut Derived Uremic Toxins and Microbiome Metabolites by Multispecies Synbiotic
| NCT ID | NCT07443280 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tungs' Taichung Metroharbour Hospital |
| Condition | Symbiotic |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-05-04 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2026-05-04 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07443280 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Symbiotic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07443280 currently recruiting?
Yes, NCT07443280 is actively recruiting participants. Contact the research team at jamespslim@gmail.com for enrollment information.
Where is the NCT07443280 trial being conducted?
This trial is being conducted at Taichung, Taiwan.
Who is sponsoring the NCT07443280 clinical trial?
NCT07443280 is sponsored by Tungs' Taichung Metroharbour Hospital. The trial plans to enroll 30 participants.