RecruitingNot ApplicableNCT05071131

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

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

Sponsor

Charite University, Berlin, Germany

Enrollment

40 participants

Start Date

Feb 1, 2022

Study Type

INTERVENTIONAL

Conditions

Chronic Kidney Disease 5D

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria11

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
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:
BMI range was changed from 25 - 39,9 to 18,5 - 39,9 kg/m²
Last visit was brought foward by 4 weeks.