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 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT02748356
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥6 years, and
2. Spina bifida and neuropathic bladder, as determined by the attending physician, and
3. Utilization of intermittent catheterization for bladder management, and
4. History of 2 or more urinary tract infections (UTIs) in the past year, and
5. Community dwelling.
Exclusion Criteria:
1. Has a known genitourinary pathology beyond neuropathic bladder (e.g. vesicoureteral reflux, bladder stones, kidney stones, etc), and/or
2. Uses prophylactic antibiotics, and/or
3. Uses intravesicular agents to reduce UTI (e.g. gentamycin), and/or
4. Has psychologic or psychiatric conditions influencing the ability to follow instructions, and/or
5. Participates in another study in which results would be confounded, and/or
6. Is pregnant or breastfeeding, and/or
7. Has a history of acquired or genetic immunodeficiencies, or active, acute or chronic serious infections (e.g. viral hepatitides, HIV/AIDs), and/or
8. Has cancer or an autoimmune disorder, and/or
9. Has a serious allergy to any component or excipients in the live bacterial combination product, and/or
10. Has had a change in neurologic status in the previous 2 weeks, and/or
11. Has taken antibiotic for any reason in the previous 2 weeks, and/or
12. Has a history of sensitivity or allergy to ampicillin or tetracycline, and/or
13. Has a current urinary tract infection or urinary tract infection within the previous 2 weeks (as defined by Infectious Diseases Society of America CAUTI Guidelines, 2010).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Study:
NCT02748356
Study Brief:
Protocol Section:
NCT02748356