MedTrace Logo

Low Protein Diet, Gut Microbiome and Chronic Kidney Disease

NCT05019599 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-08-25

No results posted yet for this study

Summary

Chronic kidney disease (CKD) is a worldwide public health dilemma because of close association with multiple comorbidities, demanding high cardiovascular events, mortality and expensive medical cost. Novel and effective therapeutic measures remain urgently needed to reduce burden and impact of disease. Advanced renal failure can profoundly alter the biochemical milieu of the gastrointestinal tract leading to a leak gut. Application of 16s rRNA gene analysis identified an increase of Clostridia, Actinobacteria, and Gammaproteobacteria in hemodialysis patients and decrease of Bifidobacterium and lactobacillus in peritoneal patients. This altered microbiome consequently affect production of indole or phenol derived uremic toxins leading to renal damage. Our preliminary results indicated reduced number and diversity of intestinal microbes CKD patients compared to normal. Different dietary nutrients can affect the gut microbiome and derive several deleterious metabolites leading to metabolic disarrangement. Clinically, low-protein diet should be prescribe to renal patients to preserve renal function and high fat content are usually recommended to avoid caloric malnutrition to dietary restriction. The changes of diet-microbiome-metabolite interaction are large unknown with this dietary manipulation. The aims of this study is to determine the renal progression-associated gene and taxonomic alterations bymetagenome-wide association studies and the functional characterization of gut microbiome in CKD patients receiving different low-protein or high-fat diets. The results of the study will provide insight on the exact role of dietary manipulation in CKD patients from gut-renal cross talk.

Conditions

  • Chronic Kidney Diseases

Interventions

OTHER

low protein diet

Low protein diet (\<0.8g/kg/BW/day)

Sponsors & Collaborators

  • Ministry of Science and Technology, Taiwan

    collaborator OTHER_GOV

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • I Wen Wu · Chang Gung Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2020-07-31
Completion
2021-10-31

Countries

  • Taiwan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05019599 on ClinicalTrials.gov