Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-24 @ 10:21 PM
NCT ID:
NCT04698135
Eligibility Criteria:
Inclusion Criteria:
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 Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04698135
Study Brief:
Protocol Section:
NCT04698135