Status:
COMPLETED
NATURE 3.1_New Approach for the Reduction of REnal Uremic Toxins
Lead Sponsor:
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Collaborating Sponsors:
University of Bari Aldo Moro
Conditions:
Chronic Kidney Diseases
Healthy
Eligibility:
All Genders
30-65 years
Phase:
NA
Brief Summary
The objective of the pilot study is to validate the clinical use of an innovative symbiotic in patients with chronic kidney disease (CKD) stage 3b-4 and in healthy subjects. The study aims at evaluat...
Eligibility Criteria
Inclusion
- CKD patients
- CKD patients stage 3b-4 not on dialysis
- Aged between 30 to 65
- BMI between 18.5 and 29.9
- Controlled diet
- Informed consent signed
Exclusion
- Type 2 diabetes mellitus
- Use of antibiotics or probiotics up to 30 days prior to recruitment
- Chronic gastrointestinal disorders
- Systemic inflammatory diseases
- Suspicion or clinical diagnosis of malignancy
- Chronic liver disease
- Treatment with corticosteroids or immunosuppressive drugs
- Previous acute cardiovascular diseases (myocardial infarction, stroke)
- Psychiatric conditions reducing the compliance to treatment protocols
- Healthy volunteers
- Inclusion Criteria:
- Healthy subjects
- Aged between 35 to 60
- BMI between 18.5 and 29.9
- Medium score of adherence to Mediterranean Diet (PREDIMED score between 6 and 9)
- Informed consent signed
Key Trial Info
Start Date :
May 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2017
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03815786
Start Date
May 24 2017
End Date
October 17 2017
Last Update
February 15 2022
Active Locations (1)
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1
AUO Policlinico Consorziale
Bari, BA, Italy, 70125