Clinical trial NCT05071131: Effect of Inulin on Gut Microbiota and Gut Barrier in Chronic Kidney Disease
Official title: Investigating the Effect of Inulin on Gut Microbiota and Gut Barrier in Advanced Chronic Kidney Disease - a Randomised, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Disease 5D
Keywords: Hemodialysis
Fiber
Zonulin
Short chain fatty acids
Dietary analysis
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2021-10-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


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.

Primary outcomes:
measure: Plasma concentration of Zonulin-1
timeFrame: After 35 days compared to placebo
Secondary outcomes:
measure: Plasma concentration of soluble CD14
timeFrame: After 35 days compared to placebo
measure: Short-chain fatty acid-associated bacterial gene expression
timeFrame: After 35 days compared to placebo and adjusted for baseline
measure: Short-chain fatty acid-associated gene expression in immune cells
timeFrame: After 35 days compared to placebo
measure: Indole-associated bacterial gene expression
timeFrame: After 35 days compared to placebo
measure: Indole-associated gene expression in immune cells
timeFrame: After 35 days compared to placebo
measure: Fecal metabolome
timeFrame: After 35 days compared to placebo and adjusted for baseline
measure: Serum metabolome
timeFrame: After 35 days compared to placebo
measure: Serum concentration of Trimethylamine-N-Oxide (TMAO)
timeFrame: After 35 days compared to placebo
measure: Fecal microbiome taxonomy
timeFrame: After 35 days compared to placebo
measure: Activation potential of aryl hydrocarbon receptor (AhR) in serum
timeFrame: After 35 days compared to placebo and adjusted for baseline
measure: Frequency of circulating T-cell subtypes
timeFrame: After 35 days compared to placebo
measure: Office systolic blood pressure
timeFrame: After 35 days compared to placebo
measure: Office diastolic blood pressure
timeFrame: After 35 days compared to placebo
measure: Plasma concentration of IL-1
timeFrame: After 35 days compared to placebo
measure: Plasma concentration of IL-6
timeFrame: After 35 days compared to placebo
measure: Plasma concentration of TNF-alpha
timeFrame: After 35 days compared to placebo
measure: Creatinine
timeFrame: After 35 days compared to placebo
measure: Cystatin c
timeFrame: After 35 days compared to placebo
measure: Creatinine / cystatin c ratio
timeFrame: After 35 days compared to placebo
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Experimental and Clinical Research Center
Study officials:
affiliation: Charite University, Berlin, Germany
name: Anja Mähler, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite University, Berlin, Germany
name: Nicola Wilck, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite University, Berlin, Germany
name: Victoria McParland, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite University, Berlin, Germany
name: Johannes Holle, MD
role: PRINCIPAL_INVESTIGATOR
References: