NCT01818180

Brief Summary

Evaluation of the effect of URELL consumption on the occurrence of recurrent urinary tract infection (Acute cystitis, pyelonephritis and asymptomatic bacteriuria).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 26, 2013

Completed
Last Updated

March 26, 2013

Status Verified

March 1, 2013

Enrollment Period

2.3 years

First QC Date

March 19, 2013

Last Update Submit

March 21, 2013

Conditions

Urinary Tract Infection (UTI)

Outcome Measures

Primary Outcomes (1)

  • Recurrence of Urinary tract infections

    From the 4th gestational month till the end of pregnancy (about the 40th gestational week)

Study Arms (2)

Urell

EXPERIMENTAL
Dietary Supplement: URELL

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

URELLDIETARY_SUPPLEMENT
Urell
PlaceboOTHER
Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital FOCH

Suresnes, 92150, France

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Jean Marc AYOUBI, PU-PH

    Hôpital FOCH 40, rue Worth 92150 Suresnes

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2013

First Posted

March 26, 2013

Study Start

May 1, 2010

Primary Completion

September 1, 2012

Last Updated

March 26, 2013

Record last verified: 2013-03

Locations

FR(1)