Urinary Tract InfectionsNCT03019874
Observational Study With Mode of Action-Analysis of Cystorenal Cranberry Extract in Patients With Recurrent Urinary Tract Infections
An observational study of Urinary Tract Infections, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The main focus of this observational study is to analyze the possible effects of cranberry dietary supplements on the intestinal microbiota in women with recurrent uncomplicated urinary tract infections. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Cranberry Extract
- How many people
- 23 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2017to Feb 2019
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic recurrent Urinary Tract Infections
Who may be able to join
- chronic recurrent urinary tract infections (≥3 infections per year or 2 infections in the last 6 months)
Who cannot join
- renal insufficiency (GFR <60),
- anatomical or known structural causes of urinary tract infections
- regular consumption of probiotics or probiotic yogurts (at least 5x / week)
- intake of antibiotics in the last 4 weeks
- intake of Marcumar
- simultaneous participation in another study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
Berlin, 14109
About this study
The main focus of this observational study is to analyze the possible effects of cranberry dietary supplements on the intestinal microbiota in women with recurrent uncomplicated urinary tract infections. In a secondary analysis the possible influence of the microbiota changes on the recurrence frequency in the follow-up should be analyzed.
- Conditions
- Urinary Tract Infections
- Being tested
- Cranberry Extract
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranberry ExtractDietary supplement
3 x Cystorenal Cranberry plus daily for 6 months (contains 300 mg Cranberry-Extract, 100 mg Pumpkin seeds-Extract, 20 mg Vitamin C und 0,47 mg Riboflavin)
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of urinary tract infections
Measured: In the 6-month prospective observation period compared to a 6-month retrospective period
Secondary outcomes (1)
Quality of life (SF-36)
Measured: Baseline, 4 weeks, 8 weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionDec 2018
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Michalsen, Charite University, Berlin, Germany
- Investigators
- Andreas Michalsen, Prof. Dr., Principal investigator, Charité University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019874
- Sponsor's protocol ID
- Cranberry
- Status last verified
- Feb 2021
- First submitted
- 2 Jan 2017
- Last updated
- 16 Feb 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study With Mode of Action-Analysis of Cystorenal Cranberry Extract in Patients With Recurrent Urinary Tract Infections
- ClinicalTrials.gov ID
- NCT03019874
- Acronym / sponsor ID
- Cranberry
- Conditions
- Urinary Tract Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2018 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 13 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.
The main focus of this observational study is to analyze the possible effects of cranberry dietary supplements on the intestinal microbiota in women with recurrent uncomplicated urinary tract infections. In a secondary analysis the possible influence of the microbiota changes on the recurrence frequency in the follow-up should be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic recurrent Urinary Tract Infections
Key inclusion criteria (1 listed)
- chronic recurrent urinary tract infections (≥3 infections per year or 2 infections in the last 6 months)
Key exclusion criteria (6 listed)
- renal insufficiency (GFR <60),
- anatomical or known structural causes of urinary tract infections
- regular consumption of probiotics or probiotic yogurts (at least 5x / week)
- intake of antibiotics in the last 4 weeks
- intake of Marcumar
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 |
|---|---|---|
| Cranberry Extract3 x Cystorenal Cranberry plus daily for 6 months (contains 300 mg Cranberry-Extract, 100 mg Pumpkin seeds-Extract, 20 mg Vitamin C und 0,47 mg Riboflavin) | Dietary supplement | – |
Primary outcome
Number of urinary tract infections
Time frame: In the 6-month prospective observation period compared to a 6-month retrospective period
1 secondary outcome
Quality of life (SF-36)
Time frame: Baseline, 4 weeks, 8 weeks, 6 months
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 16 Feb 2021.
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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.
Andreas Michalsen, Prof. Dr. principal investigator
Charité University Medical Center
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 Infections, run by Charite University, Berlin, Germany at 1 site in Germany.
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 1 inclusion and 6 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 16 Feb 2021. 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 Germany. 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?
Number of urinary tract infections (time frame: In the 6-month prospective observation period compared to a 6-month retrospective period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Feb 2021.