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

NCT07461233 | Recruiting

• 2 other identifiers: 114109TTMHH-R1150028
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

multispecies synbiotic; hemodialysis patients; uremic toxins; gut microbiome; gut permeability

Outcome Measures

Primary Outcomes (3)

• Evaluate changes in fecal microbiomes

  This study employed \*\*whole genome sequencing (WGS)\*\* for fecal microbial analysis.Alpha diversity is estimated by species richness using the Chao1 index at the OTU level. A rarefaction curve is generated by randomly selecting a subset of sequencing data from each sample to represent the number of observed species, and a species accumulation curve is plotted to show the occurrence of new OTUs (species) with continuous sampling. For beta diversity, Bray-Curtis dissimilarities at the OTU level are calculated and analyzed using the vegan package. Differential abundance analysis was performed using statistical methods appropriate for compositional microbiome and functional gene data (such as LEfSe, ANCOM-BC, ALDEx2, MaAsLin2, or DESeq2). Multiple hypothesis testing was adjusted using the Benjamini-Hochberg false discovery rate (FDR) correction.

  1 years

• Assess the serum levels of uremic toxins

  Concentrations of indoxyl sulfate (IS), p-cresyl sulfate (PCS), indole acetic acid (IAA), and indolelactic acid (ILA) in serum and urine will be determined by high-performance liquid chromatography (HPLC) according to established protocols.

  1 years

• Assess the serum levels of and gut permeability markers

  Quantification of gut permeability markers, such as intestinal fatty acid-binding protein (I-FABP), diamine oxidase (DAO), and zonulin concentrations, using validated ELISA kits.

  1 years

Study Arms (1)

Multispecies synbiotic

EXPERIMENTAL

Participants 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.

Dietary Supplement: Multispecies Synbiotic Supplementation

Interventions

Multispecies Synbiotic Supplementation DIETARY_SUPPLEMENT

Participants 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.

Multispecies synbiotic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older receiving maintenance hemodialysis patients for at least 3 months

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tungs' Taichung Metroharbour Hospital: lead

Study Sites (1)

Tungs' Taichung Metroharbour Hospital

Taichung, Wuqi District, 435, Taiwan

RECRUITING

Study Officials

• Paik Seong Lim, PhD

  Tungs' Taichung Metroharbour Hospita

  STUDY CHAIR

Central Study Contacts

Paik Seong Lim, PhD

CONTACT

+886935045292; jamespslim@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 10, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TW (1)