Effects of inulin on gut health in patients with chronic kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the impact of a 35-day inulin supplementation on the gut microbiome and gut barrier function in patients with chronic kidney disease undergoing hemodialysis. It aims to address the insufficient fiber intake in this population, which may negatively affect their gut health. Participants will receive either inulin or a placebo, and various health parameters will be monitored throughout the study. The goal is to understand how inulin can influence bacterial metabolites and immune cell states in these patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Experimental and Clinical Research Center
  Berlin, Germany Recruiting

Study contacts

• Principal investigator: Anja Mähler, PhD — Charite University, Berlin, Germany
• Study coordinator: Victoria McParland, PhD
• Email: victoria.mcparland@charite.de
• Phone: +49 30 450 540 464

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.