Prophylactic Use of Cranberries in Recurrent Bacterial Cy... | NCT03032003

Studies
Prophylactic Use of Cranberries in Recurrent Bacterial Cystitis in Women

NCT03032003

Sponsor

University of Thessaly

Status

Unknown status

Last Update Posted

Jan 26, 2017Estimated

Enrollment

160Estimated

Phase

Not Applicable

Conditions

Recurrent Urinary Tract Infections in Women

Interventions

Cysticlean
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 15, 2017Estimated

Primary Completion Date

Mar 31, 2018Estimated

Completion Date

May 31, 2018Estimated

First Submitted Date

Jan 13, 2017

First Submission Date that Met QC Criteria

Jan 23, 2017

First Posted Date

Jan 26, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2017

Last Update Posted Date

Jan 26, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Vasileios Tzortzis, Associated Professor, University of ThessalyPrincipal Investigator

Lead Sponsor

University of ThessalyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cysticlean arm	Active Comparator	Cysticlean (2 BID for 15 days)	Other: Cysticlean
Placebo arm	Placebo Comparator	Placebo (2 BID for 15 days)	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cysticlean	Other	2 BID for 15 days	Cysticlean arm
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effectiveness of the use of Cranberries in the prevention of the recurrent UTIs is women.	Follow up with urinary cultures will be evaluated for Cranberries affection in UTIs	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vasileios Tzortzis, Associated Professor	Contact			tzorvas@otenet.gr
Michael Samarinas, Consultant	Contact			mikesamih@hotmail.com

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38214795	Derived	Tsiakoulias E, Gravas S, Hadjichristodoulou C, Oikonomou KG, Kyritsi M, Dadouli K, Matziri A, Kola K, Vacthsioli E, Tsiakoulia M, Gianniou M, Tzortzis V. Randomized, placebo-controlled, double-blinded study of prophylactic cranberries use in women with recurrent uncomplicated cystitis. World J Urol. 2024 Jan 12;42(1):27. doi: 10.1007/s00345-023-04741-0.