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 @ 1:20 PM
Ignite Modification Date:
2025-12-24 @ 1:20 PM
NCT ID:
NCT03142295
Eligibility Criteria:
Inclusion Criteria:
* Subject is premenopausal, aged ≥ 18 and ≤45 years
* Subject had recurrent UTI's (≥3 documented UTI's in the last year with documented symptom-free interval of at least 2 weeks) following the definition of a urinary tract infection: the presence of significance bacteruria (10\^3 CFU/ml or more), pyuria and fever plus one or more of the following signs and symptoms: suprapubic or flank discomfort, dysuria, bladder spasms or pollakiuria
* Subject has a documented urinary tract infection (see definition), for which oral antibiotic therapy has been initiated.
* Subject has adequate understanding of the procedures of the study and agrees to abide strictly thereby.
* Subject is able to communicate well with the investigators and is available to attend all study visits.
* Subject has signed informed consent.
* Subject will remain available during the first 3 weeks of the study period (recruiting, intervention and first follow-up).
Exclusion Criteria:
* Any history, or evidence at screening, of clinically significant symptoms, physical signs or abnormal laboratory values suggestive of systemic conditions, such as cardiovascular, pulmonary, renal, hepatic, neurological, dermatological, endocrine, malignant, haematological, immune-deficient, psychiatric and other disorders, which could compromise the health of the recipient during the study. These include, but are not limited to, any of the following: positive HIV, HBV or HCV screening tests; the use of immune modifying drugs within three months prior to study onset (inhaled and topical corticosteroids and oral anti-histamines exempted) or expected use of such during the study period.
* Documented vesico-urethral reflux
* Documented urinary retention \> 100 milliliters post-void residual urine
* Anatomic urogenital abnormalities
* Urolithiasis
* Nephrostomy catheters
* Extra-urogenital infections that require prolonged antibiotic therapy
* Pregnancy
* Use of probiotics and or cranberry juice
* Allergy or intolerance for multiple common prescribed antibiotics
* Carriage of multi drug resistant organisms in faeces and/or urine without regular antibiotic treatment options
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03142295
Study Brief:
Protocol Section:
NCT03142295