Urinary Tract Infection (UTI)NCT01818180
Urell and Pregnancy
A study testing URELL in people with Urinary Tract Infection (UTI), run by Hopital Foch at 1 site in France.
Trial summary
Evaluation of the effect of URELL consumption on the occurrence of recurrent urinary tract infection (Acute cystitis, pyelonephritis and asymptomatic bacteriuria). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Urinary Tract Infection (UTI)
- What is being tested?
- URELL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- May 2010to Sep 2012
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant woman in her 4th gestational month or more, having urinary tract infection.
Who cannot join
- Pregnant woman with organic or functional urinary tract malformations
- Diabetic patients
- HIV positive
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of URELL(Cranberry Vaccinium Macrocarpon)Consumption on the Prevalence of Recurrent Urinary Tract Infection and Asymptomatic Bacteriuria During Pregnancy.
Evaluation of the effect of URELL consumption on the occurrence of recurrent urinary tract infection (Acute cystitis, pyelonephritis and asymptomatic bacteriuria).
- Conditions
- Urinary Tract Infection (UTI)
- Being tested
- URELL, Placebo
- 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.
URELLDietary supplement
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Urell | Experimental | Not described Receives: Dietary Supplement: URELL |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of Urinary tract infections
Measured: From the 4th gestational month till the end of pregnancy (about the 40th gestational week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2013 (estimated)
- Study startMay 2010
- Primary completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract Infection (UTI)Studies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Marc AYOUBI, PU-PH, Study chair, Hôpital FOCH 40, rue Worth 92150 Suresnes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818180
- Sponsor's protocol ID
- 2009/19
- Status last verified
- Mar 2013
- First submitted
- 19 Mar 2013
- Last updated
- 26 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of URELL(Cranberry Vaccinium Macrocarpon)Consumption on the Prevalence of Recurrent Urinary Tract Infection and Asymptomatic Bacteriuria During Pregnancy.
- ClinicalTrials.gov ID
- NCT01818180
- Acronym / sponsor ID
- 2009/19
- Conditions
- Urinary Tract Infection (UTI)
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Sep 2012 (actual)
- First posted
- 26 Mar 2013 (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.
Evaluation of the effect of URELL consumption on the occurrence of recurrent urinary tract infection (Acute cystitis, pyelonephritis and asymptomatic bacteriuria).
Study design
- Allocation
- Randomised
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urell | Experimental | Dietary Supplement: URELL |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant woman in her 4th gestational month or more, having urinary tract infection.
Key exclusion criteria (3 listed)
- Pregnant woman with organic or functional urinary tract malformations
- Diabetic patients
- HIV positive
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 |
|---|---|---|
| URELL | Dietary supplement | Urell |
| Placebo | Other | Placebo |
Primary outcome
Recurrence of Urinary tract infections
Time frame: From the 4th gestational month till the end of pregnancy (about the 40th gestational week)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2013.
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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.
Jean Marc AYOUBI, PU-PH study chair
Hôpital FOCH 40, rue Worth 92150 Suresnes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing URELL in people with Urinary Tract Infection (UTI), run by Hopital Foch at 1 site in France.
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 3 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: stopped early, as of the sponsor's last update on 26 Mar 2013. 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 France. 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. 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?
The study was stopped early. Results are not available in the source record.
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?
Recurrence of Urinary tract infections (time frame: From the 4th gestational month till the end of pregnancy (about the 40th gestational week)). 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 26 Mar 2013.