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

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ClinicalTrials.gov Identifier: NCT02637986
Recruitment Status : Not yet recruiting
First Posted : December 22, 2015
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
HaEmek Medical Center, Israel

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Urinary Tract Infections (UTIs) Dietary Supplement: Urex Plus - containing L. rhamnosus GR-1 and L. reuteri RC-14 Other: Placebo - capsule with no active ingredient Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: 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
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ARM A - suffered from one episode of UTI
Women who suffered from one episode of UTI during pregnancy before recruitment
Dietary Supplement: Urex Plus - containing L. rhamnosus GR-1 and L. reuteri RC-14
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
Other: Placebo - capsule with no active ingredient
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
Dietary Supplement: Urex Plus - containing L. rhamnosus GR-1 and L. reuteri RC-14
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
Other: Placebo - capsule with no active ingredient
2 capsules will be given per day




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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02637986


Contacts
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Contact: Enav Yefet, MD/PhD +972-52-3862160 ext +972-52 enavy1@gmail.com
Contact: Zohar Nachum, MD +972-54-7696562 ext +972-54 nachum.zo@gmail.com

Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
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Principal Investigator: Enav Yefet, MD/PhD Emek Medical Center

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Responsible Party: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT02637986     History of Changes
Other Study ID Numbers: 0173-13-EMC
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Recurrence
Urinary Tract Infections
Disease Attributes
Pathologic Processes
Urologic Diseases