Alterations of Gut Derived Uremic Toxins and Microbiome Metabolites by Multispecies Synbiotic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTungs' Taichung Metroharbour Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older receiving maintenance hemodialysis patients for at least 3 months
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Multispecies Synbiotic Supplementation
Dietary supplementParticipants will receive Renobiome multispecies synbiotic containing 30 billion CFUs per capsule, including strains of Lactobacillus rhamnosus (strain ID pending), Lactobacillus salivarius LS 159, Lactobacillus pentosus LPE 588, and Lactococcus lactis LL 358. * Dose: One capsule twice daily (morning and evening), with or without food, taken with room-temperature water. * Storage: Capsules to be kept below 25°C, in a dry, light-protected environment.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Multispecies synbioticExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evaluate changes in levels of microbial metabolites
Measurement of microbial metabolites (SCFA, e.g., butyric acid), indolelactic acid (ILA), and indolepropionic acid (IPA) concentrations.
Time frame
1 years2
Measurement of serum uremic toxins
• Concentrations of indoxyl sulfate (IS), p-cresyl sulfate (PCS), indoleacetic acid (IAA), and indolelactic acid (ILA) in serum and urine will be determined by high-performance liquid chromatography-mass spectrometry (HPLC-MS)
Time frame
1 years3
Assess modulation of inflammatory markers
• Quantification of inflammatory cytokines (IL-1, IL-6, TNF-α) Concentrations using validated ELISA kits.
Time frame
1 yearsSponsors and contacts
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Source ClinicalTrials.gov