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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 November 2022 |
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Main ID: |
NCT02637986 |
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Date of registration:
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16/12/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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 |
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Date of first enrolment:
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November 7, 2022 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02637986 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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N/A
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Contacts
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Name:
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Enav Yefet, MD/PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Emek Medical Center |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Urinary Tract Infections (UTIs)
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Intervention(s)
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Other: Placebo - capsule with no active ingredient
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Dietary Supplement: Urex Plus - containing L. rhamnosus GR-1 and L. reuteri RC-14
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Primary Outcome(s)
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The rate of women who developed UTI after receiving probiotic formula versus placebo.
[Time Frame: 1 year]
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Secondary Outcome(s)
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The number of UTIs during pregnancy.
[Time Frame: 1 year]
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The rate of women who suffer from obstetrical outcomes (preterm labor, intrauterine growth restriction).
[Time Frame: 1 year]
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The rate of women who suffer from bacteruria, cystitis and pyelonephritis.
[Time Frame: 1 year]
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Adverse effects of the probiotic capsules versus placebo
[Time Frame: 1 year]
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Duration of time from the beginning of study until an episode of UTI.
[Time Frame: 1 year]
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Secondary ID(s)
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0173-13-EMC
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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