Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The investigatore decided not to proceed with this study
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM A - suffered from one episode of UTI | Experimental | Women who suffered from one episode of UTI during pregnancy before recruitment |
|
| ARM A - suffered from one episode of UTI - placebo | Placebo Comparator | Women who suffered from one episode of UTI during pregnancy before recruitment |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urex Plus - containing L. rhamnosus GR-1 and L. reuteri RC-14 | Dietary Supplement | 2 capsules will be given per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Enav Yefet, MD/PhD | Emek Medical Center | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo - capsule with no active ingredient | Other | 2 capsules will be given per day |
|
| 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 |
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C011481 | methenamine hippurate |
Not provided
Not provided
Not provided