Effect of Inulin on Gut Microbiota and Gut Barrier in Chronic Kidney Disease
Recruiting · NCT05071131 · Interventional (participants receive a specific treatment) · Lead sponsor: Charite University, Berlin, Germany
View the official record on ClinicalTrials.gov →Interventions studied
InulinPlacebo
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Experimental and Clinical Research Center - Berlin, Germany