The Efficacy of Orally Administrated Probiotic Formula in Preventing a Recurrence of a Urinary Tract Infection During Pregnancy

November 7, 2022 updated by: HaEmek Medical Center, Israel

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

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.

Study Overview

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

Interventional

Phase

  • Not Applicable

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

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

  • 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

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

Investigators

  • Principal Investigator: Enav Yefet, MD/PhD, Emek Medical Center

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 (ACTUAL)

November 7, 2022

Primary Completion (ACTUAL)

November 7, 2022

Study Completion (ACTUAL)

November 7, 2022

Study Registration Dates

First Submitted

December 16, 2015

First Submitted That Met QC Criteria

December 20, 2015

First Posted (ESTIMATE)

December 22, 2015

Study Record Updates

Last Update Posted (ACTUAL)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 7, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Urinary Tract Infections (UTIs)

Clinical Trials on Urex Plus - containing L. rhamnosus GR-1 and L. reuteri RC-14

3
Subscribe