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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: February 2022

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.

Interventions

  • Dietary Supplement: Urex Plus – containing L. rhamnosus GR-1 and L. reuteri RC-14
    • 2 capsules will be given per day
  • Other: Placebo – capsule with no active ingredient
    • 2 capsules will be given per day

Arms, Groups and Cohorts

  • Experimental: ARM A – suffered from one episode of UTI
    • Women who suffered from one episode of UTI during pregnancy before recruitment
  • Placebo Comparator: ARM A – suffered from one episode of UTI – placebo
    • Women who suffered from one episode of UTI during pregnancy before recruitment
  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • Duration of time from the beginning of study until an episode of UTI.
    • Time Frame: 1 year
  • The number of UTIs during pregnancy.
    • Time Frame: 1 year
  • The rate of women who suffer from bacteruria, cystitis and pyelonephritis.
    • Time Frame: 1 year
  • The rate of women who suffer from obstetrical outcomes (preterm labor, intrauterine growth restriction).
    • Time Frame: 1 year
  • Adverse effects of the probiotic capsules versus placebo
    • Time Frame: 1 year

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • HaEmek Medical Center, Israel
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Enav Yefet, MD/PhD, Principal Investigator, Emek Medical Center
  • Overall Contact(s)
    • Enav Yefet, MD/PhD, +972-52-3862160, enavy1@gmail.com

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