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Prophylactic Use of Cranberries in Recurrent Bacterial Cystitis in Women

NCT03032003 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2017-01-26

No results posted yet for this study

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.

Conditions

  • Recurrent Urinary Tract Infections in Women

Interventions

OTHER

Cysticlean

2 BID for 15 days

OTHER

Placebo

2 BID for 15 days

Sponsors & Collaborators

  • University of Thessaly

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-15
Primary Completion
2018-03-31
Completion
2018-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03032003 on ClinicalTrials.gov