Prophylactic Use of Cranberries in Recurrent Bacterial Cystitis in Women
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|ClinicalTrials.gov Identifier: NCT03032003|
Recruitment Status : Unknown
Verified January 2017 by Vasileios Tzortzis, University of Thessaly.
Recruitment status was: Not yet recruiting
First Posted : January 26, 2017
Last Update Posted : January 26, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Urinary Tract Infections in Women||Other: Cysticlean Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Prophylactic Use of Cranberries in Recurrent Bacterial Cystitis in Women: A Randomized, Comparative, Study.|
|Estimated Study Start Date :||February 15, 2017|
|Estimated Primary Completion Date :||March 31, 2018|
|Estimated Study Completion Date :||May 31, 2018|
Active Comparator: Cysticlean arm
Cysticlean (2 BID for 15 days)
2 BID for 15 days
Placebo Comparator: Placebo arm
Placebo (2 BID for 15 days)
2 BID for 15 days
- Effectiveness of the use of Cranberries in the prevention of the recurrent UTIs is women. [ Time Frame: 12 months ]Follow up with urinary cultures will be evaluated for Cranberries affection in UTIs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032003
|Contact: Vasileios Tzortzis, Associated Professorfirstname.lastname@example.org|
|Contact: Michael Samarinas, Consultantemail@example.com|