Testing inulin fiber supplement effects on gut bacteria in advanced kidney disease
Tests inulin fiber supplement against placebo in adults with advanced chronic kidney disease.
Plain-language title generated from the registry record
Registry title: Effect of Inulin on Gut Microbiota and Gut Barrier in Chronic Kidney Disease
Key facts
- Where
- Berlin, GermanySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT05071131, who can take part
Where in Germany
- Experimental and Clinical Research CenterBerlin, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Charite University, Berlin, Germany
- Trial code
- NCT05071131
- Record updated
- 25 June 2024
- Original description
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.Read full original descriptionShow less
Investigating the Effect of Inulin on Gut Microbiota and Gut Barrier in Advanced Chronic Kidney Disease - a Randomised, Placebo-controlled Trial
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.
Inclusion: 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: 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:; Malignant diseases; Acute infections; 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; 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.