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

NCT07443280 | Recruiting

• 2 other identifiers: 114108TTMHH-R1150027
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Symbiotic; Uremic Toxins; Gut -Microbiota

Keywords

multispecies synbiotic; uremic toxins; gut microbiome; hemodialysis patients

Outcome Measures

Primary Outcomes (3)

• Evaluate changes in levels of microbial metabolites

  Measurement of microbial metabolites (SCFA, e.g., butyric acid), indolelactic acid (ILA), and indolepropionic acid (IPA) concentrations.

  1 years

• 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)

  1 years

• Assess modulation of inflammatory markers

  • Quantification of inflammatory cytokines (IL-1, IL-6, TNF-α) 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

Related Publications (15)

• Lim PS, Wang HF, Lee MC, Chiu LS, Wu MY, Chang WC, Wu TK. The Efficacy of Lactobacillus-Containing Probiotic Supplementation in Hemodialysis Patients: A Randomized, Double-Blind, Placebo-Controlled Trial. J Ren Nutr. 2021 Mar;31(2):189-198. doi: 10.1053/j.jrn.2020.07.002. Epub 2020 Sep 6.

  PMID: 32900583 BACKGROUND

• Meijers BK, Evenepoel P. The gut-kidney axis: indoxyl sulfate, p-cresyl sulfate and CKD progression. Nephrol Dial Transplant. 2011 Mar;26(3):759-61. doi: 10.1093/ndt/gfq818. No abstract available.

  PMID: 21343587 BACKGROUND

• Andrade-Oliveira V, Amano MT, Correa-Costa M, Castoldi A, Felizardo RJ, de Almeida DC, Bassi EJ, Moraes-Vieira PM, Hiyane MI, Rodas AC, Peron JP, Aguiar CF, Reis MA, Ribeiro WR, Valduga CJ, Curi R, Vinolo MA, Ferreira CM, Camara NO. Gut Bacteria Products Prevent AKI Induced by Ischemia-Reperfusion. J Am Soc Nephrol. 2015 Aug;26(8):1877-88. doi: 10.1681/ASN.2014030288. Epub 2015 Jan 14.

  PMID: 25589612 BACKGROUND

• Vanholder R, Argiles A, Baurmeister U, Brunet P, Clark W, Cohen G, De Deyn PP, Deppisch R, Descamps-Latscha B, Henle T, Jorres A, Massy ZA, Rodriguez M, Stegmayr B, Stenvinkel P, Wratten ML. Uremic toxicity: present state of the art. Int J Artif Organs. 2001 Oct;24(10):695-725.

  PMID: 11817319 BACKGROUND

• Vaziri ND. Effect of Synbiotic Therapy on Gut-Derived Uremic Toxins and the Intestinal Microbiome in Patients with CKD. Clin J Am Soc Nephrol. 2016 Feb 5;11(2):199-201. doi: 10.2215/CJN.13631215. Epub 2016 Jan 15. No abstract available.

  PMID: 26772192 BACKGROUND

• Ramezani A, et al. Gut microbiome in CKD: challenges and opportunities. Transl Res. 2016.

  BACKGROUND

• Gryp T, et al. Gut microbiota and uremic toxins in chronic kidney disease: friends or foes? Toxins. 2017.

  BACKGROUND

• Barreto FC, et al. Indoxyl sulfate, p-cresyl sulfate and outcomes in CKD patients. J Am Soc Nephrol. 2009.

  BACKGROUND

• Felizardo RJF, et al. The interplay between gut microbiota, inflammation, and CKD progression. Front Med. 2017.

  BACKGROUND

• Vanholder R, et al. Uremic toxins and gut microbiota in CKD: therapeutic implications. Clin J Am Soc Nephrol. 2014.

  BACKGROUND

• Evenepoel P, et al. Impact of dietary fiber and prebiotics on CKD progression. Kidney Int. 2021.

  BACKGROUND

• Wong J, et al. Intestinal microbiome in patients with CKD: alterations and therapeutic potential. Nat Rev Nephrol. 2014.

  BACKGROUND

• Anders HJ, et al. Dysbiosis and kidney diseases: lessons learned from translational research. Kidney Int. 2018.

  BACKGROUND

• Ramezani A, Raj DS. The gut microbiome, kidney disease, and targeted interventions. J Am Soc Nephrol. 2014 Apr;25(4):657-70. doi: 10.1681/ASN.2013080905. Epub 2013 Nov 14.

  PMID: 24231662 BACKGROUND

• Vaziri ND, et al. Chronic kidney disease, dysbiosis, and the intestinal microbiome. J Ren Nutr. 2012.

  BACKGROUND

Central Study Contacts

Paik Seong Lim, PhD

CONTACT

+886935045292; jamespslim@gmail.com

Ming Ying Wu, MS/MSc

CONTACT

+886933682221; ying5430@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 24, 2026
• First Posted: March 2, 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)