About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men and women in a ratio of 1:1
Age 18-75 years
Body mass index 25.0 - 39.9 kg/m²
End-stage kidney disease, which has been treated regularly with hemodialysis for at least 3 months
Disqualifiers
Malignant diseases
Recent or current hospitalization
Postoperative phase
Acute infections
Trial design
Parallel
Treatments tested in this trial
Inulin
Dietary supplement1 sachet à 15 grams daily for 7 days, followed by 2 sachets à 15 grams daily for 28 days
Placebo
Dietary supplement1 sachet à 15 grams daily for 7 days, followed by 2 sachets à 15 grams daily for 28 days
Treatment groups
Trial outcomes
Primary outcomes
Plasma concentration of Zonulin-1
Measured by ELISA \[ng/ml\]
Secondary outcomes
Plasma concentration of soluble CD14
Measured by ELISA \[ng/ml\]
Short-chain fatty acid-associated bacterial gene expression
Measured by quantitative PCR
Short-chain fatty acid-associated gene expression in immune cells
Measured by quantitative PCR
Indole-associated bacterial gene expression
Measured by quantitative PCR
Sponsors and contacts
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