NCT07461233 Modulation of Gut Microbiota Composition and Gut Permeability Profiles by Multispecies Synbiotic Supplementation in Hemodialysis Patients
| NCT ID | NCT07461233 |
| 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
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 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
Paik Seong Lim, PhD
STUDY CHAIR
Tungs' Taichung Metroharbour Hospita
Frequently Asked Questions
Who can join the NCT07461233 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 NCT07461233 currently recruiting?
Yes, NCT07461233 is actively recruiting participants. Contact the research team at jamespslim@gmail.com for enrollment information.
Where is the NCT07461233 trial being conducted?
This trial is being conducted at Taichung, Taiwan.
Who is sponsoring the NCT07461233 clinical trial?
NCT07461233 is sponsored by Tungs' Taichung Metroharbour Hospital. The principal investigator is Paik Seong Lim, PhD at Tungs' Taichung Metroharbour Hospita. The trial plans to enroll 30 participants.