Ignite Creation Date:
2024-05-06 @ 9:39 AM
Last Modification Date:
2024-10-26 @ 12:17 PM
Study NCT ID:
NCT03032003
Status:
UNKNOWN
Last Update Posted:
2017-01-26
First Post:
2017-01-13
Brief Title:
Prophylactic Use of Cranberries in Recurrent Bacterial Cystitis in Women
Sponsor:
University of Thessaly
Organization:
University of Thessaly
Study Overview
Official Title:
Prophylactic Use of Cranberries in Recurrent Bacterial Cystitis in Women A Randomized Comparative Study
Status:
UNKNOWN
Status Verified Date:
2017-01
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None