Prophylactic Use of Cranberries in Recurrent Bacterial Cystitis in Women

Study Overview
=================
Brief Summary
-----------------
To investigate if oral administration of 240mg PAC of cranberries can reduce the number of episodes of acute bacterial cystitis and improve general QoL in women with recurrent bacterial cystitis. In addition, the effect on vagina and rectal flora will studied and the adverse effect profile of the drug will be reported. Women with ≥3 symptomatic episodes of lower UTIs at the previous year will be recruited from the outpatient population who present to their family physician or specialist with symptomatic recurrent UTI. Informed consent will be obtained from all patients and they will be divided in groups according to their age. Urinary culture, vaginal and rectal swab will be taken from all the patients. Antibiotic treatment will be prescribed (using the drug of choice according to the urine culture and the treating physician choice). Subsequently, they will be randomized to receive combined antibiotic treatment with one capsule of Cysticlean 240mg PAC two times per day or antibiotic treatment with placebo. At 14th day post treatment and after a negative urinary culture patients will continue to receive per os, daily, one capsule of Cysticlean 240mg at bed time for 12 months or placebo respectively. Study visits will occur at 3rd, 6th , 9th and 12th month treatment phase. A urine collection, vaginal swabs and rectal swab will be taken at study entry and at the month 3, 6, 9 and 12 visits. Participants will be asked about medication usage, any side effects they may be experiencing at each study visit. If participants develop a UTI at any time during the study, they will be asked to visit the study site within 24 hours.

Official Title
-----------------
Prophylactic Use of Cranberries in Recurrent Bacterial Cystitis in Women: A Randomized, Comparative, Study.

Conditions
-----------------
Recurrent Urinary Tract Infections in Women

Intervention / Treatment
-----------------
* Other: Cysticlean
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Negative urine culture At least 3 UTI's within 12 months prior to study entry Exclusion Criteria: Anatomic abnormalities of the urinary tract Use of investigational drugs within 30 days prior to study entry Current use of warfarin Allergy or intolerance of cranberry products > 50 ml of residual urine (measured by US) Use of indwelling catheter uncontrolled diabetes creatinine > 250 mmol/l, Symptomatic vaginitis Pregnant or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cysticlean arm<br>Cysticlean (2 BID for 15 days) | Other: Cysticlean<br>* 2 BID for 15 days<br>|
| Placebo Comparator: Placebo arm<br>Placebo (2 BID for 15 days) | Other: Placebo<br>* 2 BID for 15 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of the use of Cranberries in the prevention of the recurrent UTIs is women. | Follow up with urinary cultures will be evaluated for Cranberries affection in UTIs | 12 months |