NCT05071131 Effect of Inulin on Gut Microbiota and Gut Barrier in Chronic Kidney Disease
| NCT ID | NCT05071131 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Charite University, Berlin, Germany |
| Condition | Chronic Kidney Disease 5D |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-02-01 |
| Primary Completion | 2026-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2022-02-01 with a primary completion date of 2026-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Anja Mähler, PhD
PRINCIPAL INVESTIGATOR
Charite University, Berlin, Germany
Frequently Asked Questions
Who can join the NCT05071131 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Chronic Kidney Disease 5D. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05071131 currently recruiting?
Yes, NCT05071131 is actively recruiting participants. Contact the research team at victoria.mcparland@charite.de for enrollment information.
Where is the NCT05071131 trial being conducted?
This trial is being conducted at Berlin, Germany.
Who is sponsoring the NCT05071131 clinical trial?
NCT05071131 is sponsored by Charite University, Berlin, Germany. The principal investigator is Anja Mähler, PhD at Charite University, Berlin, Germany. The trial plans to enroll 40 participants.
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