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:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT02660333
Eligibility Criteria:
Inclusion Criteria:
* Age greater than 18 years and less than 60 years
* Body mass index (BMI)≥40kg/m2
Exclusion Criteria:
* Previous gastrointestinal diseases (e.g. cancer and inflammatory bowel disease)
* Intolerances and/or food allergies (e.g. lactose intolerance and celiac disease)
* Current use of anti-inflammatory drugs and/or antibiotics and/or immunosuppressants
* Regular use of laxatives and/or appetite suppressants
* Current or previous use (up to one month) of prebiotics, probiotics, synbiotics or products enriched with these food compounds
* Intolerance to prebiotic and/or probiotic and/or synbiotic
* Following a diet for weight loss in the last three months
* Pregnant or breastfeeding
* Following unusual diets (e.g. vegetarian, macrobiotic)
* Alcohol dependence and/or illicit drugs dependence
* Smokers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02660333
Study Brief:
Protocol Section:
NCT02660333