Urell and Pregnancy

March 21, 2013 updated by: Hopital Foch

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Suresnes, France, 92150
        • Hôpital FOCH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

- Pregnant woman in her 4th gestational month or more, having urinary tract infection.

Exclusion Criteria:

  • Pregnant woman with organic or functional urinary tract malformations
  • Diabetic patients
  • HIV positive

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Other: Placebo
EXPERIMENTAL: Urell
Dietary supplement: URELL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence of Urinary tract infections
Time Frame: From the 4th gestational month till the end of pregnancy (about the 40th gestational week)
From the 4th gestational month till the end of pregnancy (about the 40th gestational week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Investigators

  • Study Chair: Jean Marc AYOUBI, PU-PH, Hôpital FOCH 40, rue Worth 92150 Suresnes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ACTUAL)

September 1, 2012

Study Registration Dates

First Submitted

March 19, 2013

First Submitted That Met QC Criteria

March 21, 2013

First Posted (ESTIMATE)

March 26, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 26, 2013

Last Update Submitted That Met QC Criteria

March 21, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/19

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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