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 @ 10:45 PM
Ignite Modification Date:
2025-12-24 @ 10:45 PM
NCT ID:
NCT06093035
Eligibility Criteria:
Inclusion Criteria:
For both populations:
* childbearing age
* no antibiotic therapies in the last 30 days
* no urinary tract infections/diseases in the last 30 days
* no surgical interventions in the last 90 days
* no intake of prebiotics or probiotics in the last 60 days
* no estrogen-progestin or steroid hormone therapy in the last 60 days
* no sexual intercourse in the last 3 days
* no local vaginal therapy in the last 60 days
* signing of the informed consent;
* patients without lower urinary tract disorders (only for the control group);
* patients with neurogenic bladder secondary to spina bifida (only for the study group).
Exclusion Criteria:
For both populations:
* kidney or urinary tract stones
* presence of pre-existing or ongoing intestinal pathologies (Inflammatory Bowel Diseases, chronic hepatitis, celiac disease, neoplasms, previous extensive intestinal resections)
* ongoing diarrhea of any origin (defined as more than 6 evacuations of watery stools per day and/or faecal volume in 24 hours greater than 250 ml)
* ongoing septic status
* state of pregnancy
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT06093035
Study Brief:
Protocol Section:
NCT06093035