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

RecruitingNAAges 18 Years - 75 YearsAllCharite University, Berlin, Germany
NCT05071131 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Inulin
  • Placebo
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Where

1 site
Experimental and Clinical Research Center
Berlin, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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