Multispecies Synbiotic in hemodialysis patients with CKD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, open-label pilot study enrolling adults on maintenance hemodialysis to see if 12 weeks of a multispecies synbiotic (Renobiome) can reduce gut-derived uremic toxins and inflammatory markers. Participants will take one capsule twice daily and undergo baseline and 12-week assessments of serum and urinary toxins, plus gut microbial metabolites. Safety monitoring occurs at 4 weeks, and outcomes include changes in indoxyl sulfate, p-cresyl sulfate, and related inflammatory markers. The study plans to enroll about 30 participants to detect a medium effect size with adequate power. Results will inform whether multispecies synbiotics merit further testing in larger trials.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tungs' Taichung Metroharbour Hospital
  Taichung, Wuqi District, Taiwan Recruiting

Study contacts

• Study coordinator: Paik Seong Lim, PhD
• Email: jamespslim@gmail.com
• Phone: +886935045292

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.