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

  • End date
    Feb 1, 2025
  • participants needed
  • sponsor
    Charite University, Berlin, Germany
Updated on 4 October 2022


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.

Condition Chronic Kidney Disease 5D
Treatment Placebo, Inulin
Clinical Study IdentifierNCT05071131
SponsorCharite University, Berlin, Germany
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Malignant diseases
Recent or current hospitalization
Postoperative phase
Acute infections
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
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