NCT05570929
Recruiting
Not Applicable
Observation of Alterations in Kidney Function, Immune System and Gut Mircobiota After Living Donor Kidney Transplantation
ConditionsChronic Kidney Diseases
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Kidney Diseases
- Sponsor
- Charite University, Berlin, Germany
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Fecal microbiome taxonomy (Shannon-Index)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
This is a longitudinal observation of kidney function, immune system and gut microbiota before and 24 weeks after a live kidney transplantation conducted in donor and recipient pairs living in the same household. Outcome measures include kidney function, body composition, blood pressure, gut microbiome composition, metabolomics and immune cell states.
Investigators
Till Schütte
Principle Investigator
Charite University, Berlin, Germany
Eligibility Criteria
Inclusion Criteria
- •Body-Mass-Index 18,5 - 34,9 kg/m2
- •Planned living kidney donation / transplantation
Exclusion Criteria
- •Clinically relevant heart, lung, liver, and kidney diseases
- •Postoperative phase
- •Acute infections
- •Vegan diet
- •Change of body weight of more than 10% in the month prior to study entry
- •Known drug or alcohol abuse
Outcomes
Primary Outcomes
Fecal microbiome taxonomy (Shannon-Index)
Time Frame: Change from Baseline at 24 weeks
Measured by 16S amplicon sequencing
Secondary Outcomes
- Fat free mass(Change from Baseline at 24 weeks)
- Serum short-chain fatty acid concentration(Change from Baseline at 24 weeks)
- Fecal short-chain fatty acid concentration(Change from Baseline at 24 weeks)
- Office systolic blood pressure(Change from Baseline at 24 weeks)
- Functional capacity of gut microbiota(Change from Baseline at 24 weeks)
- Fecal tryptophan metabolites concentration(Change from Baseline at 24 weeks)
- Body fat content(Change from Baseline at 24 weeks)
- Frequency of circulating T-cell subtypes(Change from Baseline at 24 weeks)
- Serum tryptophan metabolites concentration(Change from Baseline at 24 weeks)
- Office diastolic blood pressure(Change from Baseline at 24 weeks)
Study Sites (1)
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