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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: March 14, 2017

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.

Interventions

  • Dietary Supplement: Urex Plus
    • Probiotic
  • Other: Placebo
    • capsule without active ingredient
  • Dietary Supplement: Probotic capsule containing L. rhamnosus GR-1and L. reuteri RC-14

Arms, Groups and Cohorts

  • Experimental: Primary prevention – Urex Plus
    • Patients with Normal vaginal flora in the experimental arm will be treated with UREX PLUS
  • Placebo Comparator: Primary prevention – Placebo
    • Patients with Normal vaginal flora in the Placebo arm will be treated with a capsule without active ingredient
  • Experimental: Secondary prevention – Urex Plus
    • Patients with abnormal vaginal flora in the experimental arm will be treated with antibiotic (either clindamycin, metronidazole or both if one was not effective), Once AVF/BV was eradicated, the patient will be given UREX PLUS
  • Placebo Comparator: Secondary prevention – Placebo
    • Patients with abnormal vaginal flora in the Placebo arm will be treated with antibiotic (either clindamycin, metronidazole or both if one was not effective), Once AVF/BV was eradicated, the patient will be given placebo without active ingredient
  • Experimental: Eradication – Urex Plus
    • Patients with persistent abnormal vaginal flora following treatment with clindamycin and metronidazole in the experimental arm will be treated with UREX PLUS
  • Placebo Comparator: Eradication – Placebo
    • Patients with persistent abnormal vaginal flora following treatment with clindamycin and metronidazole in the placebo arm will be treated with placebo without active ingredient
  • Other: Lactobacilli transfer – probiotic capsule
    • Patients with Normal vaginal flora will be treated with a probotic capsule containing L. rhamnosus GR-1and L. reuteri RC-14 for two months afterwhich they will receive no treatment for additional two months. Lactobacili colonization in the vaginal flora will be tested
  • Other: Lactobacilli transfer – probiotic capsule after 2 months
    • Patients with Normal vaginal flora will be followed for two months without intervention afterwhich they will receive a probotic capsule containing L. rhamnosus GR-1and L. reuteri RC-14 for two months. Lactobacili colonization in the vaginal flora will be tested.

Clinical Trial Outcome Measures

Primary Measures

  • The amount of lactobacilli in the vaginal
    • Time Frame: once a month until week 36.6 of labor
    • Lactobacilli culture will be made from a vaginal specimen. The pattern of bacterial growth will be used for a semi-quantitative interpretation in a scale of 0-no vaginal colonization to 4-substantial colonization.
  • The rate of women with normal vaginal flora at enrollment, who developed AVF/BV during the study period
    • Time Frame: From date of randomization until the date of first documented episode or until delivery (around 4 months)
  • The rate of women with AVF/BV at enrollment whose infection was eradicated following antibiotics, who developed AVF/BV during the study period
    • Time Frame: From date of randomization until the date of first documented episode or until delivery (around 4 months)
  • 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
    • Time Frame: Until delivery (around 4 months)

Secondary Measures

  • Duration of time from the beginning of the study until an episode of AVF/BV
    • Time Frame: From date of randomization until the date of first documented episode or until delivery (around 4 months)
  • The number of episodes of BV/AVF during pregnancy
    • Time Frame: Until delivery (around 4 months)
  • 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)
    • Time Frame: Until delivery (around 4 months)
  • The rate and type of adverse effects in the probiotic versus placebo groups
    • Time Frame: Until delivery (around 4 months)
  • Number of urinary tract infections during the study period
    • Time Frame: Until delivery (around 4 months)

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • HaEmek Medical Center, Israel
  • Provider of Information About this Clinical Study
    • Principal Investigator: enav yefet, MD/PhD – HaEmek Medical Center, Israel
  • Overall Official(s)
    • ENAV YEFET, MD/PhD, Principal Investigator, HaEmek Medical Center , Afula

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