Low Protein Diet, Gut Microbiome and Chronic Kidney Disease

Chronic Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05019599
• Other study ID #: IWW-0008
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: October 31, 2021

Study information

• Verified date: January 2021
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: October 31, 2021
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 90 Years

Eligibility

Inclusion Criteria:

1. . Patients aged 30-90 years with diagnosis of CKD (defined as abovementioned).

2. . Sign the inform consent and agree to participate in this study.

3. . Compliant to low protein diet (defined as protein intake <0.8 g/Kg/day) for 4 weeks assessed by 24h urine urea estimates, before enrollment

Exclusion Criteria:

1. . History of any malignancy, liver cirrhosis, intestinal operation, irritable bowel syndrome, cardiovascular disease (defined as myocardial infarction, documented Q wave on EKG, unstable angina, coronary artery disease with stenosis > 75%, congestive heart failure with Ejection Fraction < 50% and cerebrovascular disease) in the past 3 months.

2. . History of or infection disease requiring admission in the past 3 months or, concomitant antibiotics use.

3. . Concomitant use of probiotics or prebiotics.

4. . Pregnancy.

5. . Renal transplant recipients.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• low protein diet
Low protein diet (<0.8g/kg/BW/day)

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Keelung

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	Ministry of Science and Technology, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Wu IW, Lee CC, Hsu HJ, Sun CY, Chen YC, Yang KJ, Yang CW, Chung WH, Lai HC, Chang LC, Su SC. Compositional and Functional Adaptations of Intestinal Microbiota and Related Metabolites in CKD Patients Receiving Dietary Protein Restriction. Nutrients. 2020 S — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of gut microbiota	change of relative abundance of microbes	3 months
Primary	change of host metabolite concentration	change of concentration of serum metabolomic profile	3 months
Primary	change of renal function	serum creatinine, estimated glomerular filtration rate or urine total protein	3 months

External Links

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