Actively Recruiting
Investigating the Effect of Inulin on Gut Microbiota and Gut Barrier in Advanced Chronic Kidney Disease - a Randomised, Placebo-controlled Trial
Led by Charite University, Berlin, Germany · Updated on 2024-06-25
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of inulin supplementation on the gut microbiome, gut barrier function, bacterial metabolites, and immune cell states in patients with advanced chronic kidney disease undergoing hemodialysis. This randomized, placebo-controlled trial aims to understand how fiber intake impacts these factors, as chronic kidney disease patients often have insufficient dietary fiber. The study is sponsored by Charite University, Berlin, Germany. Participants will receive either inulin or a placebo (maltodextrin) over a 35-day period. The intervention starts with 15 grams daily for 7 days, followed by 30 grams daily for 28 days. The study design includes a quadruple masking and random allocation to either inulin or placebo groups to assess the effects of the dietary supplement on gut health and kidney disease-related outcomes. During the trial, participants' plasma concentration of Zonulin-1 will be measured after 35 days as the primary outcome. Secondary outcomes include various markers such as soluble CD14, gene expression related to short-chain fatty acids and indole in bacteria and immune cells, fecal and serum metabolomes, blood pressure, inflammatory cytokines, kidney function markers, and immune cell frequencies. The total study duration includes these assessments, with ongoing monitoring of safety and adherence throughout the intervention period.
CONDITIONS
Brief Title
Effect of Inulin on Gut Microbiota and Gut Barrier in Chronic Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women in a ratio of 1:1
- Age 18-75 years
- Body mass index 18.5 - 39.9 kg/m²
- End-stage kidney disease treated regularly with hemodialysis for at least 3 months
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 35 days
Participants receive inulin or placebo dietary supplements daily, starting with 15 grams per day for 7 days, followed by 30 grams per day for 28 days.
Weekly visits during treatment
Trial Site Locations
Total: 1 location
1
Experimental and Clinical Research Center
Berlin, Germany, 13125
Actively Recruiting
Research Team
V
Victoria McParland, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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