Effect of Inulin on Gut Microbiota and Gut Barrier in Chronic Kidney Disease

Chronic Kidney Disease 5D Clinical Trial

— RESTORE  

Official title:

Investigating the Effect of Inulin on Gut Microbiota and Gut Barrier in Advanced Chronic Kidney Disease - a Randomised, Placebo-controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05071131
• Other study ID #: RESTORE
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: February 1, 2027

Study information

• Verified date: February 2024
• Source: Charite University, Berlin, Germany
• Contact: Victoria McParland, PhD
• Phone: +49 30 450 540 464
• Email: victoria.mcparland[@]charite.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An adequate fiber intake is crucial for a well-balanced diet and reduces the risk of chronic diseases. However, nutritional recommendations for chronic kidney disease patients lead to an insufficient fiber intake with possible maladaptive effects on the gut microbiome. Therefore, we want to study the effects of a 35-day inulin supplementation on the gut microbiome, gut barrier function, bacterial metabolites and immune cell states in chronic kidney disease patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 1, 2027
• Est. primary completion date: February 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Men and women in a ratio of 1:1
• Age 18-75 years
• Body mass index 25.0 - 39.9 kg/m^2
• End-stage kidney disease, which has been treated regularly with hemodialysis for at least 3 months

Exclusion Criteria:

• Malignant diseases
• Recent or current hospitalization
• Postoperative phase
• Acute infections
• Malnutrition
• Antibiotic treatment within the last 4 weeks
• Regular intake of probiotics and/or prebiotics
• Change of body weight of more than 2 kg in the month prior to study entry
• Known drug or alcohol abuse

Changes applied in July 2022 according to amendment no. 1:

• Two inclusion criteria were changed to improve recruitment
• Age range was changed from 18-70 to 18-75 years
• BMI range was changed from 18.5 - 34.9 to 25.0 - 39.9 kg/m^2
• The intervention scheme was adapted to increase patient adherence
• A 7-day adaption phase with half of the dose (15 grams per day) at the start of the intervention was introduced, changing treatment duration from 28 to 35 days

Changes applied in January 2024 according to amendment no. 2:

• One inclusion criteria was changed to improve recruitment
• BMI range was changed from 25 - 39,9 to 18,5 - 39,9 kg/m²
• Last visit was brought foward by 4 weeks.

Related Conditions & MeSH terms

• Chronic Kidney Disease 5D
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• Inulin
1 sachet à 15 grams daily for 7 days, followed by 2 sachets à 15 grams daily for 28 days
• Placebo
1 sachet à 15 grams daily for 7 days, followed by 2 sachets à 15 grams daily for 28 days

Locations

Country	Name	City	State
Germany	Experimental and Clinical Research Center	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration of Zonulin-1	Measured by ELISA [ng/ml]	After 35 days compared to placebo
Secondary	Plasma concentration of soluble CD14	Measured by ELISA [ng/ml]	After 35 days compared to placebo
Secondary	Short-chain fatty acid-associated bacterial gene expression	Measured by quantitative PCR	After 35 days compared to placebo and adjusted for baseline
Secondary	Short-chain fatty acid-associated gene expression in immune cells	Measured by quantitative PCR	After 35 days compared to placebo
Secondary	Indole-associated bacterial gene expression	Measured by quantitative PCR	After 35 days compared to placebo
Secondary	Indole-associated gene expression in immune cells	Measured by quantitative PCR	After 35 days compared to placebo
Secondary	Fecal metabolome	Measured by mass spectrometry	After 35 days compared to placebo and adjusted for baseline
Secondary	Serum metabolome	Measured by mass spectrometry	After 35 days compared to placebo
Secondary	Serum concentration of Trimethylamine-N-Oxide (TMAO)	Measured by LC-MS [µM]	After 35 days compared to placebo
Secondary	Fecal microbiome taxonomy	Measured by 16S amplicon sequencing	After 35 days compared to placebo
Secondary	Activation potential of aryl hydrocarbon receptor (AhR) in serum	Measured by cell-based luciferase reporter assay (delta luminescence)	After 35 days compared to placebo and adjusted for baseline
Secondary	Frequency of circulating T-cell subtypes	Measured by flow cytometry (%)	After 35 days compared to placebo
Secondary	Office systolic blood pressure	Mean of five consecutive blood pressure measurements (mmHg)	After 35 days compared to placebo
Secondary	Office diastolic blood pressure	Mean of five consecutive blood pressure measurements (mmHg)	After 35 days compared to placebo
Secondary	Plasma concentration of IL-1	Measured by ELISA [pg/ml]	After 35 days compared to placebo
Secondary	Plasma concentration of IL-6	Measured by ELISA [pg/ml]	After 35 days compared to placebo
Secondary	Plasma concentration of TNF-alpha	Measured by ELISA [pg/ml]	After 35 days compared to placebo
Secondary	Creatinine	Creatine serum concentration	After 35 days compared to placebo
Secondary	Cystatin c	Cystatin c serum concentration	After 35 days compared to placebo
Secondary	Creatinine / cystatin c ratio	Measured in serum	After 35 days compared to placebo