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

NCT02430246 | Terminated

• 1 other identifier: 0096-13
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (4)

• The amount of lactobacilli in the vaginal

  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.

  once a month until week 36.6 of labor

• The rate of women with normal vaginal flora at enrollment, who developed AVF/BV during the study period

  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

  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

  Until delivery (around 4 months)

Secondary Outcomes (5)

• Duration of time from the beginning of the study until an episode of AVF/BV

  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

  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)

  Until delivery (around 4 months)

• The rate and type of adverse effects in the probiotic versus placebo groups

  Until delivery (around 4 months)

• Number of urinary tract infections during the study period

  Until delivery (around 4 months)

Study Arms (8)

Primary prevention - Urex Plus

EXPERIMENTAL

Patients with Normal vaginal flora in the experimental arm will be treated with UREX PLUS

Dietary Supplement: Urex Plus

Primary prevention - Placebo

PLACEBO COMPARATOR

Patients with Normal vaginal flora in the Placebo arm will be treated with a capsule without active ingredient

Other: Placebo

Secondary prevention - Urex Plus

EXPERIMENTAL

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

Dietary Supplement: Urex Plus

Secondary prevention - Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Eradication - Urex Plus

EXPERIMENTAL

Patients with persistent abnormal vaginal flora following treatment with clindamycin and metronidazole in the experimental arm will be treated with UREX PLUS

Dietary Supplement: Urex Plus

Eradication - Placebo

PLACEBO COMPARATOR

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: Placebo

Lactobacilli transfer - probiotic capsule

OTHER

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

Dietary Supplement: Probotic capsule containing L. rhamnosus GR-1and L. reuteri RC-14

Lactobacilli transfer - probiotic capsule after 2 months

OTHER

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.

Dietary Supplement: Probotic capsule containing L. rhamnosus GR-1and L. reuteri RC-14

Interventions

Urex Plus DIETARY_SUPPLEMENT

Probiotic

Eradication - Urex Plus; Primary prevention - Urex Plus; Secondary prevention - Urex Plus

Placebo OTHER

capsule without active ingredient

Eradication - Placebo; Primary prevention - Placebo; Secondary prevention - Placebo

Probotic capsule containing L. rhamnosus GR-1and L. reuteri RC-14 DIETARY_SUPPLEMENT

Lactobacilli transfer - probiotic capsule; Lactobacilli transfer - probiotic capsule after 2 months

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

HaEmek Medical Center

Afula, Israel

Location

MeSH Terms

Interventions

methenamine hippurate

Study Officials

• ENAV YEFET, MD/PhD

  HaEmek Medical Center , Afula

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD/PhD

Study Record Dates

• First Submitted: April 20, 2015
• First Posted: April 30, 2015
• Study Start: January 1, 2016
• Primary Completion: March 14, 2017
• Study Completion: January 10, 2019
• Last Updated: December 17, 2019

Record last verified: 2019-12

Locations

IL (1)