Prophylactic Use of Cranberries in Recurrent Bacterial Cystitis in Women

NCT ID: NCT03032003

Last Updated: 2017-01-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-15
• Study Completion Date: 2018-05-31

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.

Conditions

Recurrent Urinary Tract Infections in Women

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cysticlean arm

Cysticlean (2 BID for 15 days)

Group Type: ACTIVE_COMPARATOR

Cysticlean

Intervention Type: OTHER

2 BID for 15 days

Placebo arm

Placebo (2 BID for 15 days)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

2 BID for 15 days

Interventions

Cysticlean

2 BID for 15 days

Intervention Type: OTHER

Placebo

2 BID for 15 days

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Thessaly

OTHER

Sponsor Role: lead

Responsible Party

Vasileios Tzortzis

Associated Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Vasileios Tzortzis, Associated Professor

Role: CONTACT

tzorvas@otenet.gr

Michael Samarinas, Consultant

Role: CONTACT

mikesamih@hotmail.com

References

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.

Reference Type: DERIVED

PMID: 38214795 (View on PubMed)

Other Identifiers

Cranberries1

Identifier Type: -

Identifier Source: org_study_id