Ignite Creation Date:
2024-05-06 @ 7:55 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02637986
Status:
WITHDRAWN
Last Update Posted:
2022-11-08
First Post:
2015-12-16
Brief Title:
The Efficacy of Orally Administrated Probiotic Formula in Preventing a Recurrence of a Urinary Tract Infection During Pregnancy
Sponsor:
HaEmek Medical Center Israel
Organization:
HaEmek Medical Center Israel
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The investigatore decided not to proceed with this study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Urinary tract infections UTIs the most common infection in pregnancyare 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
Detailed Description:
Background Urinary tract infections UTIs the most common infection in pregnancyare 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 aimsAdministration of oral probiotic formula to pregnant womenwhich 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
Working hypothesis and aimsAdministration of oral probiotic formula to pregnant womenwhich 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None