Recurrent Urinary Tract Infections in WomenNCT03032003
Prophylactic Use of Cranberries in Recurrent Bacterial Cystitis in Women
A study testing Cysticlean in people with Recurrent Urinary Tract Infections in Women, run by University of Thessaly.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Recurrent Urinary Tract Infections in Women
- What is being tested?
- Cysticlean
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2017to 31 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Negative urine culture
- At least 3 UTI's within 12 months prior to study entry
Who cannot join
- 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
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- uncontrolled diabetes
- creatinine > 250 mmol/l,
- Symptomatic vaginitis
- Pregnant or breastfeeding
Trial locations and contacts
No sites are listed yet.
Vasileios Tzortzis, Associated Professor contact
Michael Samarinas, Consultant contact
About this study
Official title: Prophylactic Use of Cranberries in Recurrent Bacterial Cystitis in Women: A Randomized, Comparative, Study.
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.
Read more
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.
- Being tested
- Cysticlean, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CysticleanOther
2 BID for 15 days
PlaceboOther
2 BID for 15 days
| Study group | Role | What they receive |
|---|---|---|
| Cysticlean arm | Active comparator | Cysticlean (2 BID for 15 days) Receives: Other: Cysticlean |
| Placebo arm | Placebo comparator | Placebo (2 BID for 15 days) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start15 Feb 2017 (estimated)
- Primary completion31 Mar 2018 (estimated)
- Study completion31 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Urinary Tract Infections in WomenStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vasileios Tzortzis, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032003
- Sponsor's protocol ID
- Cranberries1
- Status last verified
- Jan 2017
- First submitted
- 13 Jan 2017
- Last updated
- 26 Jan 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38214795
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Use of Cranberries in Recurrent Bacterial Cystitis in Women: A Randomized, Comparative, Study.
- ClinicalTrials.gov ID
- NCT03032003
- Acronym / sponsor ID
- Cranberries1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 15 Feb 2017 (estimated)
- Primary completion
- 31 Mar 2018 (estimated)
- Study completion
- 31 May 2018 (estimated)
- First posted
- 26 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cysticlean arm | Active comparator | Other: CysticleanCysticlean (2 BID for 15 days) |
| Placebo arm | Placebo comparator | Other: PlaceboPlacebo (2 BID for 15 days) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Negative urine culture
- At least 3 UTI's within 12 months prior to study entry
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cysticlean2 BID for 15 days | Other | Cysticlean arm |
| Placebo2 BID for 15 days | Other | Placebo arm |
Primary outcome
Effectiveness of the use of Cranberries in the prevention of the recurrent UTIs is women.
Time frame: 12 months
Follow up with urinary cultures will be evaluated for Cranberries affection in UTIs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
- Derived from this study: PubMed 38214795Tsiakoulias 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vasileios Tzortzis, Associated Professor contact
Michael Samarinas, Consultant contact
Questions about this trial
What is this clinical trial studying?
A study testing Cysticlean in people with Recurrent Urinary Tract Infections in Women, run by University of Thessaly.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vasileios Tzortzis, Associated Professor (tzorvas@otenet.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the use of Cranberries in the prevention of the recurrent UTIs is women. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03032003, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2017.