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NCT07461233From ClinicalTrials.govRecruiting

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

  • Symbiotic
  • Uremic Toxins
  • Gut -Microbiota
  • Gut Permeability
  • Hemodialysis

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
Tungs' Taichung Metroharbour Hospital
Enrolment target
30
Started
4 May 2026
Main results due
31 December 2026
Study sites
1
Registry updated
25 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(1)

  • Tungs' Taichung Metroharbour Hospital

    Taichung, Wuqi District, Taiwan

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07461233. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Modulation of Gut Microbiota Composition and Gut Permeability Profiles by Multispecies Synbiotic Supplementati | Trialion