NCT05071131Recruiting
Effect of Inulin on Gut Microbiota and Gut Barrier in Chronic Kidney Disease
Investigating the Effect of Inulin on Gut Microbiota and Gut Barrier in Advanced Chronic Kidney Disease - a Randomised, Placebo-controlled Trial
Source: ClinicalTrials.gov · Last updated 25 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 16 Sept 2021
- Start date
- 1 Feb 2022
- Primary completion date
- 1 Feb 2026
- Lead sponsor
- Charite University, Berlin, Germany
- Diseases
- Chronic kidney disease
- NCT number
- NCT05071131
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 1 Feb 2022 to the primary completion date, 1 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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:
Other illness
- Malignant diseases
- Acute infections
Age
- 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
Other
- Recent or current hospitalization
- Postoperative phase
- Malnutrition
- Antibiotic treatment within the last 4 weeks
- Regular intake of probiotics and/or prebiotics
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Experimental and Clinical Research Center Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.