Effects of inulin on gut health in patients with chronic kidney disease
Investigating the Effect of Inulin on Gut Microbiota and Gut Barrier in Advanced Chronic Kidney Disease - a Randomised, Placebo-controlled Trial
This study tests whether taking inulin for 35 days can improve gut health in people with chronic kidney disease who are on hemodialysis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 1 site (Berlin) |
| Trial ID | NCT05071131 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 18-75 with end-stage kidney disease on regular hemodialysis.
Not a fit: Patients with malignant diseases, recent hospitalizations, or those on antibiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve gut health and overall well-being in patients with chronic kidney disease.
How similar studies have performed: Other studies have shown promising results with fiber supplementation in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Berlin
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.