Effect of Inulin on Gut Microbiota and Gut Barrier in Chronic Kidney Disease
NCT ID: NCT05071131
Last Updated: 2024-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2022-02-01
2027-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Inulin
15 grams inulin per day for 7 days, followed by 30 grams inulin per day for 28 days
Inulin
1 sachet à 15 grams daily for 7 days, followed by 2 sachets à 15 grams daily for 28 days
Placebo
15 grams maltodextrin per day for 7 days, followed by 30 grams maltodextrin per day for 28 days
Placebo
1 sachet à 15 grams daily for 7 days, followed by 2 sachets à 15 grams daily for 28 days
Interventions
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Inulin
1 sachet à 15 grams daily for 7 days, followed by 2 sachets à 15 grams daily for 28 days
Placebo
1 sachet à 15 grams daily for 7 days, followed by 2 sachets à 15 grams daily for 28 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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:
* BMI range was changed from 25 - 39,9 to 18,5 - 39,9 kg/m²
* Last visit was brought foward by 4 weeks.
Exclusion Criteria
* 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:
18 Years
75 Years
ALL
No
Sponsors
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Charite University, Berlin, Germany
OTHER
Responsible Party
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Till Schütte
Principle Investigator
Principal Investigators
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Anja Mähler, PhD
Role: PRINCIPAL_INVESTIGATOR
Charite University, Berlin, Germany
Nicola Wilck, MD
Role: PRINCIPAL_INVESTIGATOR
Charite University, Berlin, Germany
Victoria McParland, PhD
Role: PRINCIPAL_INVESTIGATOR
Charite University, Berlin, Germany
Johannes Holle, MD
Role: PRINCIPAL_INVESTIGATOR
Charite University, Berlin, Germany
Locations
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Experimental and Clinical Research Center
Berlin, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RESTORE
Identifier Type: -
Identifier Source: org_study_id
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