Status:
COMPLETED
Establishment of the Human Intestinal and Salivary Microbiota Biobank - Obesity
Lead Sponsor:
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Collaborating Sponsors:
University of Bari Aldo Moro
University of Salento
Conditions:
Morbid Obesity
Metabolically Healthy Obesity
Eligibility:
All Genders
18-60 years
Brief Summary
This is a prospective, clinical, multicentre study aimed to collect biological samples and study microbiota from subjects with morbid obesity, metabolically healthy obesity and from healthy volunteers...
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 selected di...
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
- SUBJECTS WITH MORBID OBESITY
- subjects aged between 18 and 60 years
- subjects having morbid obesity (BMI ≥ 35 kg/m2), as following at least two of the following conditions: insulin resistance, prediabetes or type 2 diabetes mellitus, dyslipidemia, cardiovascular (arterial hypertension) and respiratory (obstructive sleep apnea) diseases
- omnivorous diet
- signature of the informed consent
- SUBJECTS WITH METABOLICALLY HEALTHY OBESITY
- subjects aged between 18 and 60 years
- Obese subjects (BMI ≥ 35 kg/m2) metabolically healthy, without or with only one of the following : insulin resistance, prediabetes or type 2 diabetes mellitus, dyslipidemia, cardiovascular (arterial hypertension) and respiratory (obstructive sleep apnea) diseases
- omnivorous diet
- signature of the informed consent
Exclusion
- HEALTHY VOLUNTEERS/SUBJECTS WITH MORBID OBESITY/ METABOLICALLY HEALTHY OBESITY
- 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 :
March 25 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 30 2022
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT04698135
Start Date
March 25 2021
End Date
July 30 2022
Last Update
January 13 2023
Active Locations (1)
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1
Azienda Ospedaliera Universitaria Policlinico di Bari - U.O.C. Endocrinologia Universitaria (D.E.T.O.)
Bari, Italy