Association Between Fecal Microbiota Composition, Metabolite Concentrations, and Indoxyl Sulfate Levels

NCT06877585 | Completed

• 2 other identifiers: 113097TTMHH-R1140050
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Gut dysbiosis is frequently characterized by decreased microbial diversity and alterations in the abundance of certain microbial species. In individuals with chronic kidney disease (CKD), dysbiosis and metabolic imbalances are prevalent, contributing to the buildup of gut-derived retention solutes and metabolites in the bloodstream. Research has consistently shown that CKD patients exhibit lower levels of beneficial gut bacteria. However, the specific functional changes in gut microbiota and their interactions with levels of uremic toxins in hemodialysis (HD) patients remain incompletely understood. This study seeks to explore the association of fecal metagenomics and targeted metabolomics in a cohort of 60 patients with different levels of to characterize the complex interplay between the gut microbiome and fecal and serum metabolites.

Conditions

Dysbiosis

Keywords

gut microbiome; gut dysbiosis; hemodialysis patients; indoxyl sulfate

Outcome Measures

Primary Outcomes (1)

• Fecal microbiota profile

  Alpha diversity, Beta diversity and functional composition of metagenomes is predicted from 16S rRNA data using the PICRUSt software with Python scripts

  1 years

Secondary Outcomes (5)

• Measurement of serum uremic toxins

  1 years

• Evaluation of short-chain fatty acids(SCFAs) and branched-chain SCFAs

  1 years

• Measurement of serum uremic toxins

  1 years

• Measurement of serum uremic toxins

  1 years

• Measurement of serum uremic toxins

  1 years

Study Arms (1)

Hemodialysis Patients

This study seeks to explore the association of fecal metagenomics and targeted metabolomics in a cohort of 60 patients with different levels of to characterize the complex interplay between the gut microbiome and fecal and serum metabolites.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

hemodialysis patients

You may qualify if:

• age 18-80 years and
• diagnosed with CKD stage V
• currently receiving hemodialysis treatment\>3 months

You may not qualify if:

• pregnant or nursing women
• patients with kidney transplant
• severe infections
• severe cardiac diseases
• liver diseases
• malignancy
• autoimmune disorders
• severe malnutrition
• consumed any type of pre-or probiotics
• had antibiotic therapy within 1 month
• diagnosed irritable bowel syndrome
• Crohn's disease
• ulcerative colitis

Sponsors & Collaborators

• Tungs' Taichung Metroharbour Hospital: lead

Study Sites (1)

Tungs' Taichung Metroharbour Hospital

Taichung, Wuqi District, 435, Taiwan

Location

Related Publications (29)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and stool

MeSH Terms

Conditions

Dysbiosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paik Seong Lim, PhD

  Tungs' Taichung Metroharbour Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: April 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

TW (1)