NCT03032003

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 26, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

February 15, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

1.1 years

First QC Date

January 13, 2017

Last Update Submit

January 23, 2017

Conditions

Recurrent Urinary Tract Infections in Women

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

CysticleanOTHER

2 BID for 15 days

Cysticlean arm
PlaceboOTHER

2 BID for 15 days

Placebo arm

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Negative urine culture
  • At least 3 UTI's within 12 months prior to study entry

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 38214795DERIVED

MeSH Terms

Interventions

Cysticlean

Central Study Contacts

Vasileios Tzortzis, Associated Professor

CONTACT

tzorvas@otenet.gr

Michael Samarinas, Consultant

CONTACT

mikesamih@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

January 13, 2017

First Posted

January 26, 2017

Study Start

February 15, 2017

Primary Completion

March 31, 2018

Study Completion

May 31, 2018

Last Updated

January 26, 2017

Record last verified: 2017-01