Clinical Trials Directory

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UnknownNCT05019599

Low Protein Diet, Gut Microbiome and Chronic Kidney Disease

Exploring the Role of Low Protein Diet on the Gut Microbiome, Related Metabolites and Renal Function in Chronic Kidney Disease

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
Chang Gung Memorial Hospital · Academic / Other
Sex
All
Age
30 Years – 90 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
OTHERlow protein dietLow protein diet (\<0.8g/kg/BW/day)

Timeline

Start date
2019-08-01
Primary completion
2020-07-31
Completion
2021-10-31
First posted
2021-08-25
Last updated
2021-08-25

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT05019599. Inclusion in this directory is not an endorsement.