NCT05019599

Low Protein Diet, Gut Microbiome and Chronic Kidney Disease

Status unknown NA Last updated 25 August 2021

What this trial tests

NA trial testing low protein diet in Chronic Kidney Diseases in 100 participants. Status unknown.

Timeline

1 August 2019

Primary endpoint
31 July 2020

31 October 2021

Quick facts

Lead sponsor	Chang Gung Memorial Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	100
Start date	1 August 2019
Primary completion	31 July 2020
Estimated completion	31 October 2021
Sites	1 location across Taiwan

Drugs / interventions tested

• low protein diet

Conditions studied

• Chronic Kidney Diseases — all drugs for Chronic Kidney Diseases →

Sponsor

Chang Gung Memorial Hospital

Who can join

Adults 30 to 90, any sex, with Chronic Kidney Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.