Clinical trial NCT02430246: The Association Between the Transfer of Lactobacilli From the Gastrointestinal Tract to the Vagina and the Prevention / Eradication of Abnormal Vaginal Flora in High Risk Pregnancies
Official title: The Association Between the Transfer of Lactobacilli From the Gastrointestinal Tract to the Vagina and the Prevention / Eradication of Abnormal Vaginal Flora in High Risk Pregnancies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pregnancy
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2015-04-30
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pregnant women at high risk for preterm labor from at least 13 weeks of gestation will be tested to detect abnormal vaginal flora (AVF) or its severe form - bacterial vaginosis (BV) by taking vaginal smear. Treatment will be given according to the results.

Detailed description: Pregnant women at high risk for preterm labor from at least 13 weeks of gestation will be tested to detect AVF/BV by taking vaginal smear. Diagnosis will be according to the Nugent score criteria. Treatment will be given according to the results:

Patient with a positive smear for AVF- patients tested positive will be treated with either clindamycin or metronidazole. Following treatment another smear will be taken according to which the patients will be divided into 2 research groups: (1) Assessing the effectiveness of probiotic formula to prevent AVF re-infection (secondary infection) - this group includes patients with normal vaginal flora following antibiotic administration. (2) Assessing the effectiveness of probiotic formula to eradicate AVF - this group includes patients with persistent AVF following antibiotic administration (first and second line). In each group the patients will be divided into a research group which will receive the probiotic formula UREX PLUS (containing L. rhamnosus GR-1and L. reuteri RC-14) and a control group which will receive a placebo twice a day until 36.6 weeks of gestation.

Patient with a negative smear for AVF - in those patients the effectiveness of probiotic formula will be tested for primary prevention. These patients 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 36.6 weeks of gestation.

Finally, the colonization of lactobacilli in the vaginal flora will be examined by dividing patients with normal vaginal flora into one group receiving a probiotic capsule containing L. rhamnosus GR-1 and L. reuteri RC-14 twice a day for 2 months and a second group without intervention. After two months the group receiving probiotic capsule will receive no treatment and the second group will receive probiotic capsule containing L. rhamnosus GR-1and L. reuteri RC-14 twice a day for 2 months.

Eligibility criteria: Inclusion Criteria:

* pregnant women from at least 13 weeks of gestation with a risk factor for preterm labor

Exclusion Criteria:

* Women with preterm premature rupture of the membranes
* Immunocompromised women
* Planned elective preterm birth for reasons other than preterm premature rupture of membranes

Primary outcomes:
measure: The amount of lactobacilli in the vaginal
timeFrame: once a month until week 36.6 of labor
measure: The rate of women with normal vaginal flora at enrollment, who developed AVF/BV during the study period
timeFrame: From date of randomization until the date of first documented episode or until delivery (around 4 months)
measure: The rate of women with AVF/BV at enrollment whose infection was eradicated following antibiotics, who developed AVF/BV during the study period
timeFrame: From date of randomization until the date of first documented episode or until delivery (around 4 months)
measure: The rate of women with AVF/BV at enrollment whose infection was not eradicated following antibiotics, who restored the normal vaginal flora during the study period
timeFrame: Until delivery (around 4 months)
Secondary outcomes:
measure: Duration of time from the beginning of the study until an episode of AVF/BV
timeFrame: From date of randomization until the date of first documented episode or until delivery (around 4 months)
measure: The number of episodes of BV/AVF during pregnancy
timeFrame: Until delivery (around 4 months)
measure: The rate of women, who suffer from obstetrical outcomes(preterm labor, intrauterine growth restriction, preterm premature rupture of membranes, chorioamnionitis, post-partum fever, post-partum endometritis, neonatal sepsis and neonatal complications)
timeFrame: Until delivery (around 4 months)
measure: The rate and type of adverse effects in the probiotic versus placebo groups
timeFrame: Until delivery (around 4 months)
measure: Number of urinary tract infections during the study period
timeFrame: Until delivery (around 4 months)
Other outcomes:
Locations:
city: Afula
country: Israel
facility: HaEmek Medical Center
Study officials:
affiliation: HaEmek Medical Center , Afula
name: ENAV YEFET, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: