Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07461233

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

Led by Tungs' Taichung Metroharbour Hospital · Updated on 2026-06-03

30

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Chronic kidney disease (CKD) patients on maintenance hemodialysis often experience significant changes in their gut bacteria, leading to harmful imbalances and increased gut leakiness. This allows toxins from the gut to enter the bloodstream, contributing to inflammation, heart disease risk, and faster CKD progression. Researchers are studying how a multispecies synbiotic supplement might improve these gut issues and reduce harmful toxins in hemodialysis patients. Participants will take a multispecies synbiotic supplement called Renobiome, containing 30 billion colony-forming units per capsule from several Lactobacillus strains and Lactococcus lactis. The supplement is taken twice daily for 12 weeks, with or without food. The study includes baseline tests of blood, urine, and stool samples, followed by monitoring of symptoms and side effects at 4 weeks and repeat testing at 12 weeks. During the trial, participants will have fasting blood samples collected and analyzed for uremic toxins and gut permeability markers. Stool samples will be examined to assess changes in gut bacteria. Adherence to the supplement will be tracked, and any adverse events will be recorded. The main outcomes measured are changes in fecal microbiome composition and serum levels of uremic toxins and gut permeability markers over one year.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Receiving maintenance hemodialysis for at least 3 months
Not Eligible

You will not qualify if you...

  • 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 such as gastrectomy or 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 weeks

Participants take a multispecies synbiotic supplement twice daily for 12 weeks to assess its effects on gut microbiota and gut permeability.

2 visits (at 4 weeks and 12 weeks)

Trial Site Locations

Total: 1 location

1

Tungs' Taichung Metroharbour Hospital

Taichung, Wuqi District, Taiwan, 435

Actively Recruiting

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Research Team

P

Paik Seong Lim, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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