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 @ 12:24 PM
Ignite Modification Date:
2025-12-24 @ 12:24 PM
NCT ID:
NCT04698161
Eligibility Criteria:
Inclusion Criteria:
PATIENTS WITH NSLSC
* NSLSC diagnosis
* aged between 18 and 75 years
* omnivorous diet
* having suspended antibiotic therapy for at least 15 days
* cessation of treatment with cortisone for at least 15 days
* signature of the informed consent
PATIENTS WITH METASTATIC MELANOMA
* metastatic melanoma diagnosis
* aged between 18 and 75 years
* omnivorous diet
* having suspended antibiotic therapy for at least 15 days
* cessation of treatment with cortisone for at least 15 days
* signature of the informed consent
Exclusion Criteria:
PATIENTS WITH NSLSC/METASTATIC MELANOMA
Exclusion criteria:
* Current treatment with antibiotics or immunosuppressive drugs Previous chemotherapy treatmment 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
* Autoimmune disorders or history of chronic and systemic autoimmune disorders
* Neurodegenerative disorders
* Pregnancy and breastfeeding
* Psychiatric conditions that reduce protocol compliance.
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04698161
Study Brief:
Protocol Section:
NCT04698161