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Prophylactic Use of Cranberries in Recurrent Bacterial Cystitis in Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Vasileios Tzortzis, University of Thessaly

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.


Condition or disease Intervention/treatment Phase
Recurrent Urinary Tract Infections in Women Other: Cysticlean Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Cysticlean arm
Cysticlean (2 BID for 15 days)
Other: Cysticlean
2 BID for 15 days

Placebo Comparator: Placebo arm
Placebo (2 BID for 15 days)
Other: Placebo
2 BID for 15 days




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Vasileios Tzortzis, Associated Professor tzorvas@otenet.gr
Contact: Michael Samarinas, Consultant mikesamih@hotmail.com

Sponsors and Collaborators
University of Thessaly
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Responsible Party: Vasileios Tzortzis, Associated Professor, University of Thessaly
ClinicalTrials.gov Identifier: NCT03032003    
Other Study ID Numbers: Cranberries1
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Tract Infections
Cystitis
Infection
Urologic Diseases
Urinary Bladder Diseases