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Prophylactic Use of Cranberries in Recurrent Bacterial Cystitis in Women

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03032003
Enrollment
160
Registered
2017-01-26
Start date
2017-02-15
Completion date
2018-05-31
Last updated
2017-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Urinary Tract Infections in Women

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.

Interventions

OTHERCysticlean

2 BID for 15 days

OTHERPlacebo

2 BID for 15 days

Sponsors

University of Thessaly
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Effectiveness of the use of Cranberries in the prevention of the recurrent UTIs is women.12 monthsFollow up with urinary cultures will be evaluated for Cranberries affection in UTIs

Contacts

Primary ContactVasileios Tzortzis, Associated Professor
tzorvas@otenet.gr
Backup ContactMichael Samarinas, Consultant
mikesamih@hotmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026