- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02637986
The Efficacy of Orally Administrated Probiotic Formula in Preventing a Recurrence of a Urinary Tract Infection During Pregnancy
The Efficacy of Orally Administrated Probiotic Formula in Preventing a Recurrence of a Urinary Tract Infection During Pregnancy - a Prospective Randomized Double Blind Placebo-control Study
Study Overview
Status
Conditions
Detailed Description
Background: Urinary tract infections (UTIs), the most common infection in pregnancy,are associated with several maternal and fetal complications, including maternal septic shock, preterm labor, intrauterine growth restriction and intrauterine fetal death. Thus, the prevention of UTIs in pregnancy is a very important goal. Several studies have suggested that alterations in the vaginal flora were associated with recurrent UTIs, and probiotic administrations may have a role in preventing those infections. Nevertheless, this has never been tested in pregnant women.
Working hypothesis and aims:Administration of oral probiotic formula to pregnant women,which suffered from at least one episode of UTI, will reduce the recurrence of future UTIs events.
Methods: A prospective randomized double blind placebo-control study. Pregnant women which suffered from at least one event of UTI during pregnancy will be divided into 2 research arms:
ARM A - women who suffered from one episode of UTI during pregnancy before recruitment: after antibiotic treatment achieving a sterile bacterial urine culture, these patients will be divided into a research group which will receive the probiotic formula Urex Plus containing L. rhamnosus GR-1 and L. reuteri RC-14, and a control group, which will receive a placebo, twice a day until delivery.
ARM B - women who suffered from more than one episode of UTI or one episode of pyelonephritis during pregnancy before recruitment will receive a preventive antibiotic treatment until delivery. Similarly to ARM A, after achieving a sterile bacterial urine culture, those women, will be divided into a research group, which will receive the probiotic formula Urex Plus, and a control group, which will receive a placebo twice a day until delivery.
Once a month and with symptoms, urine culture will be taken in all of the study arms. Vaginal swab test will also be taken to detect the presence of abnormal vaginal flora and semi-quantitative assessment of vaginal lactobacilli.
Data regarding the rate of recurrent UTIs, time until infection, average number of infections, the rate of pyelonephritis infections and obstetrical and neonatal outcomes will be collected.
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Above 18 years old
- Pregnant women who suffered from at least one episode of UTI
- Women less than 34th week of gestation at the time of the enrollment
- Urine culture is sterile in the beginning of the study
Exclusion Criteria:
- Immunocompromised women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: ARM A - suffered from one episode of UTI
Women who suffered from one episode of UTI during pregnancy before recruitment
|
2 capsules will be given per day
|
PLACEBO_COMPARATOR: ARM A - suffered from one episode of UTI - placebo
Women who suffered from one episode of UTI during pregnancy before recruitment
|
2 capsules will be given per day
|
EXPERIMENTAL: ARM B -suffered from more than one episode of UTI
women who suffered from more than one episode of UTI or one episode of pyelonephritis during pregnancy before recruitment
|
2 capsules will be given per day
|
PLACEBO_COMPARATOR: ARM B -suffered from more than one episode of UTI - placebo
women who suffered from more than one episode of UTI or one episode of pyelonephritis during pregnancy before recruitment
|
2 capsules will be given per day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The rate of women who developed UTI after receiving probiotic formula versus placebo.
Time Frame: 1 year
|
The rate of women who developed UTI after receiving probiotic formula versus placebo.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of time from the beginning of study until an episode of UTI.
Time Frame: 1 year
|
1 year
|
The number of UTIs during pregnancy.
Time Frame: 1 year
|
1 year
|
The rate of women who suffer from bacteruria, cystitis and pyelonephritis.
Time Frame: 1 year
|
1 year
|
The rate of women who suffer from obstetrical outcomes (preterm labor, intrauterine growth restriction).
Time Frame: 1 year
|
1 year
|
Adverse effects of the probiotic capsules versus placebo
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Enav Yefet, MD/PhD, Emek Medical Center
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0173-13-EMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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Clinical Trials on Urex Plus - containing L. rhamnosus GR-1 and L. reuteri RC-14
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