RecruitingNot Applicable

Alterations of Gut Derived Uremic Toxins and Microbiome Metabolites by Multispecies Synbiotic

Taiwan30 participantsStarted 2026-05-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. 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 (gastrectomy, 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evaluate changes in levels of microbial metabolites

Timeframe: 1 years

Measurement of serum uremic toxins

Timeframe: 1 years

Assess modulation of inflammatory markers

Timeframe: 1 years

Trial details

NCT IDNCT07443280

SponsorTungs' Taichung Metroharbour Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Paik Seong Lim, PhD

+886935045292 jamespslim@gmail.com

View on ClinicalTrials.gov More Symbiotic trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. 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 (gastrectomy, 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.