Status:
COMPLETED
Establishment of the Human Intestinal and Salivary Microbiota Biobank - Metabolic Syndrome
Lead Sponsor:
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Collaborating Sponsors:
Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies
Istituti Tumori Giovanni Paolo II
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
18-60 years
Brief Summary
This is a prospective, clinical, monocentric study aimed to collect biological samples and study microbiota from subjects suffering from metabolic syndrome and from healthy volunteers. Microbiota is a...
Detailed Description
The primary aim of this multicentric study is to populate the first national microbioma biobank with biological samples (fecal, salivary, urinary and blood samples) subjects suffering from metabolic s...
Eligibility Criteria
Inclusion
- HEALTHY VOLUNTEERS
- healthy subjects aged between 18 and 60 years
- BMI between 18.5-30
- omnivorous diet
- signature of the informed consent
- PATIENTS WITH METABOLIC SYNDROME
- age between 18 and 60 years
- patients with metabolic syndrome defined as follows:
- abdominal circumference \> 94cm (males), \> 80cm (females)
- presence of at least 2 of the following 4 criteria:
- triglycerides 150 mg / dl or in specific treatment
- HDL cholesterol \<40mg / dI in women and \<50mg / dl in men
- blood pressure values\> 130/85 mmHg or hypertension under treatment
- fasting blood glucose 100 mg / dl or diabetes already diagnosed
- omnivorous diet
- signature of the informed consent
Exclusion
- HEALTHY VOLUNTEERS and PATIENTS WITH METABOLIC SYNDROME
- Exclusion criteria:
- Current or previous infectious diseases (HAV, HBV, HCV, HIV, Cytomegalovirus, Epstein-Barr virus)
- Chronic liver disease
- History of Clostridium difficile infections
- Recent (\<3 months) therapy with antibiotics, immunosuppressive drugs, chemotherapy
- Chronic therapy with proton pump inhibitors
- Recent (\<3 months) use of probiotics, laxatives or other aids (drugs / supplements) for the regulation of gastrointestinal activity
- Previous history of organ / tissue transplantation
- Recent onset of diarrhea
- Chronic diarrhea
- Chronic constipation
- Previous gastrointestinal surgery (eg gastric bypass)
- Recurring urinary tract infections (3 cases per year)
- Previous major acute cardiovascular diseases (myocardial infarction, stroke)
- Type 2 diabetes mellitus
- Hypertension
- eGFR (estimated glomerular filtration rate) lower than 60ml / minute and / or diagnosis of nephropathy
- Chronic gastrointestinal disorders
- Systemic inflammatory diseases
- Suspicion, clinical diagnosis or previous history of cancer (\<5 years)
- Autoimmune disorders or history of chronic and systemic autoimmune disorders
- Neurodegenerative disorders
- Pregnancy and breastfeeding
- Healthcare workers
- Operators work with animals
- Psychiatric conditions that reduce protocol compliance.
Key Trial Info
Start Date :
July 20 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 7 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04698096
Start Date
July 20 2021
End Date
March 7 2022
Last Update
March 24 2022
Active Locations (1)
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1
Azienda Ospedaliera Universitaria Policlinico di Bari - Dipartimento Interdisciplinare di Medicina
Bari, Italy