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

NCT02637986 | Withdrawn

• 1 other identifier: 0173-13-EMC
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Urinary Tract Infections (UTIs)

Outcome Measures

Primary Outcomes (1)

• The rate of women who developed UTI after receiving probiotic formula versus placebo.

  The rate of women who developed UTI after receiving probiotic formula versus placebo.

  1 year

Secondary Outcomes (5)

• Duration of time from the beginning of study until an episode of UTI.

  1 year

• The number of UTIs during pregnancy.

  1 year

• The rate of women who suffer from bacteruria, cystitis and pyelonephritis.

  1 year

• The rate of women who suffer from obstetrical outcomes (preterm labor, intrauterine growth restriction).

  1 year

• Adverse effects of the probiotic capsules versus placebo

  1 year

Study Arms (4)

ARM A - suffered from one episode of UTI

EXPERIMENTAL

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

ARM A - suffered from one episode of UTI - placebo

PLACEBO COMPARATOR

Women who suffered from one episode of UTI during pregnancy before recruitment

Other: Placebo - capsule with no active ingredient

ARM B -suffered from more than one episode of UTI

EXPERIMENTAL

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

ARM B -suffered from more than one episode of UTI - placebo

PLACEBO COMPARATOR

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

Interventions

Urex Plus - containing L. rhamnosus GR-1 and L. reuteri RC-14 DIETARY_SUPPLEMENT

2 capsules will be given per day

ARM A - suffered from one episode of UTI; ARM B -suffered from more than one episode of UTI

Placebo - capsule with no active ingredient OTHER

2 capsules will be given per day

ARM A - suffered from one episode of UTI - placebo; ARM B -suffered from more than one episode of UTI - placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Immunocompromised women

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

methenamine hippurate

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Enav Yefet, MD/PhD

  Emek Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: December 22, 2015
• Study Start: November 7, 2022
• Primary Completion: November 7, 2022
• Study Completion: November 7, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share