Effect of Inulin on Gut Microbiota and Gut Barrier in Chronic Kidney Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Inulin, Placebo.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Disease 5D. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Investigating the Effect of Inulin on Gut Microbiota and Gut Barrier in Advanced Chronic Kidney Disease - a Randomised, Placebo-controlled Trial
Overview
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.
Interventions
- Dietary supplement Inulin
1 sachet à 15 grams daily for 7 days, followed by 2 sachets à 15 grams daily for 28 days - Dietary supplement Placebo
1 sachet à 15 grams daily for 7 days, followed by 2 sachets à 15 grams daily for 28 days
Primary outcome measures
- Plasma concentration of Zonulin-1 [Time frame: After 35 days compared to placebo]
Secondary outcome measures (12)
- Plasma concentration of soluble CD14 [Time frame: After 35 days compared to placebo]
- Short-chain fatty acid-associated bacterial gene expression [Time frame: After 35 days compared to placebo and adjusted for baseline]
- Short-chain fatty acid-associated gene expression in immune cells [Time frame: After 35 days compared to placebo]
- Indole-associated bacterial gene expression [Time frame: After 35 days compared to placebo]
- Indole-associated gene expression in immune cells [Time frame: After 35 days compared to placebo]
- Fecal metabolome [Time frame: After 35 days compared to placebo and adjusted for baseline]
- Serum metabolome [Time frame: After 35 days compared to placebo]
- Serum concentration of Trimethylamine-N-Oxide (TMAO) [Time frame: After 35 days compared to placebo]
- Fecal microbiome taxonomy [Time frame: After 35 days compared to placebo]
- Activation potential of aryl hydrocarbon receptor (AhR) in serum [Time frame: After 35 days compared to placebo and adjusted for baseline]
- Frequency of circulating T-cell subtypes [Time frame: After 35 days compared to placebo]
- Office systolic blood pressure [Time frame: After 35 days compared to placebo]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Basic science
Study locations
Germany · 1 center
- Experimental and Clinical Research Center — Berlin
Identifiers
NCT: NCT05071131 · RESTORE