Urinary Tract DiseaseNCT05260554
Effect of Cranberry Extract on the Urinary System
An observational study of Urinary Tract Disease and Cystitis, run by Kırklareli University at 1 site in Turkey (Türkiye).
Trial summary
In this study, we will try to emphasize the effects of using cranberry tablets, which is an alternative to antibiotic therapy, during uncomplicated urinary tract infections (only urinary tract, bladder and kidney infections did not). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Disease, Cystitis, Antibiotic Reaction
- What is being tested?
- Fosfomycin and Cranberry
- Type of treatment
- Pill or oral medicine
- How many people
- 2 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jan 2022to 18 Feb 2022
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Among the patients who were eligible criteria, the study was terminated when the number of patients in both groups reached 80.
Who may be able to join
- Older than 18
- who have urinary tract inflammation
- who haven't kidney dissease previous
Who cannot join
- Younger than 18
- Who have kidney inflammation
- Pregnant patients
- Who have blood test abnormal (WBC, Ure, Creatin, CRP high level)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Use of Cranberry Extract Instead of Antibiotics During Uncomplicated Urinary Tract Infection
In this study, we will try to emphasize the effects of using cranberry tablets, which is an alternative to antibiotic therapy, during uncomplicated urinary tract infections (only urinary tract, bladder and kidney infections did not).
Read the detailed description
This study was Istanbul Kartal Dr. Lütfi Kırdar Training and Research Hospital Emergency Medicine Clinic and Kırklareli Training and Research Hospital Emergency Service and Internal Medicine Polyclinic. Our study; includes patients who applied to the Emergency Department and Internal Medicine outpatient clinic with the complaint of dysuria and had normal WBC, CRP, urea, and creatinine values in their analysis, and leukocyturia was found in the urine test. Two options were offered in the treatment to these patients. Vaccinium Macrocarpon Aiton preparation or fosfomycin was given for seven days. The patients were asked whether their complaints had decreased according to the Lykert-Type verbal scale at the time of admission and on the first, third, and seventh days. When the treatment was finished, leukocytes were checked in the urinalysis. This outcome was compared between the 2 treatment options. We also noted whether nausea.
- Conditions
- Urinary Tract Disease, Cystitis, Antibiotic Reaction
- Being tested
- Fosfomycin, Cranberry
- Keywords
- Urinary Tract Disease, Cranberry extract, Antibiotic, Cystitis
- Medical subject headings
- Urologic Diseases, Cystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FosfomycinDrug
Also called monurol
In this group with urinary tract inflammation; Fosfomycin was prescribed for 7 days (3 doses, 2 days apart). There are 80 patients in total.
CranberryDietary supplement
In this group with urinary tract inflammation; 7 days (used every day) cranberry tablet was given. There are 80 patients in total.
| Study group | Role | What they receive |
|---|---|---|
| using fosfomycin | The patients in this group; have been prescribed fosfomycin for 7 days (3 doses, two days apart). Receives: Drug: Fosfomycin | |
| using cranberry extract | The patients in this group; took 7 days (1 tablet each day) of cranberry tablets. Receives: Dietary Supplement: Cranberry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment time
After 7 days of treatment, the 2 treatment options were compared with each other.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start26 Jan 2022
- Primary completion18 Feb 2022
- Study completion18 Feb 2022
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 Urinary Tract DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırklareli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oya Guven, MD, Kırklareli University
- Investigators
- Oya Guven, Study director, Kırklareli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260554
- Sponsor's protocol ID
- Kırklareli University
- Status last verified
- Feb 2022
- First submitted
- 18 Feb 2022
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The data results of the patients will be described in the article.
Publications
Gray M. Are cranberry juice or cranberry products effective in the prevention or management of urinary tract infection? J Wound Ostomy Continence Nurs. 2002 May;29(3):122-6. doi: 10.1067/mjw.2002.124016. No abstract available.
PubMed 12011903
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Use of Cranberry Extract Instead of Antibiotics During Uncomplicated Urinary Tract Infection
- ClinicalTrials.gov ID
- NCT05260554
- Acronym / sponsor ID
- Kırklareli University
- Conditions
- Urinary Tract Disease, Cystitis, Antibiotic Reaction
- Keywords
- Urinary Tract Disease, Cranberry extract, Antibiotic, Cystitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Kırklareli UniversityUniversity, hospital or other
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 18 Feb 2022 (actual)
- Study completion
- 18 Feb 2022 (actual)
- First posted
- 2 Mar 2022 (actual)
- 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.
In this study, we will try to emphasize the effects of using cranberry tablets, which is an alternative to antibiotic therapy, during uncomplicated urinary tract infections (only urinary tract, bladder and kidney infections did not).
Detailed description
This study was Istanbul Kartal Dr. Lütfi Kırdar Training and Research Hospital Emergency Medicine Clinic and Kırklareli Training and Research Hospital Emergency Service and Internal Medicine Polyclinic. Our study; includes patients who applied to the Emergency Department and Internal Medicine outpatient clinic with the complaint of dysuria and had normal WBC, CRP, urea, and creatinine values in their analysis, and leukocyturia was found in the urine test. Two options were offered in the treatment to these patients. Vaccinium Macrocarpon Aiton preparation or fosfomycin was given for seven days. The patients were asked whether their complaints had decreased according to the Lykert-Type verbal scale at the time of admission and on the first, third, and seventh days. When the treatment was finished, leukocytes were checked in the urinalysis. This outcome was compared between the 2 treatment options. We also noted whether nausea.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| using fosfomycin | – | Drug: FosfomycinThe patients in this group; have been prescribed fosfomycin for 7 days (3 doses, two days apart). |
| using cranberry extract | – | Dietary Supplement: CranberryThe patients in this group; took 7 days (1 tablet each day) of cranberry tablets. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Among the patients who were eligible criteria, the study was terminated when the number of patients in both groups reached 80.
Key inclusion criteria (3 listed)
- Older than 18
- who have urinary tract inflammation
- who haven't kidney dissease previous
Key exclusion criteria (4 listed)
- Younger than 18
- Who have kidney inflammation
- Pregnant patients
- Who have blood test abnormal (WBC, Ure, Creatin, CRP high level)
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 |
|---|---|---|
| FosfomycinAlso: monurolIn this group with urinary tract inflammation; Fosfomycin was prescribed for 7 days (3 doses, 2 days apart). There are 80 patients in total. | Drug | using fosfomycin |
| CranberryIn this group with urinary tract inflammation; 7 days (used every day) cranberry tablet was given. There are 80 patients in total. | Dietary supplement | using cranberry extract |
Primary outcome
Treatment time
Time frame: 7 days
After 7 days of treatment, the 2 treatment options were compared with each other.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Results publication: PubMed 12011903Gray M. Are cranberry juice or cranberry products effective in the prevention or management of urinary tract infection? J Wound Ostomy Continence Nurs. 2002 May;29(3):122-6. doi: 10.1067/mjw.2002.124016. No abstract available.
- Individual participant dataSharing planned: No. The data results of the patients will be described in the article.
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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.
Oya Guven study director
Kırklareli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Disease and Cystitis, run by Kırklareli University at 1 site in Turkey (Türkiye).
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment time (time frame: 7 days). 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 NCT05260554, 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 2 Mar 2022.