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

Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02430246
• Other study ID #: 0096-13
• Status: Terminated
• Phase: N/A
• Start date: January 2016
• Est. completion date: January 10, 2019

Study information

• Verified date: December 2019
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: January 10, 2019
• Est. primary completion date: March 14, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

Dietary Supplement:
• Urex Plus
Probiotic

Other:
• Placebo
capsule without active ingredient

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

Locations

Country	Name	City	State
Israel	HaEmek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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)
Primary	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	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)
Secondary	The number of episodes of BV/AVF during pregnancy		Until delivery (around 4 months)
Secondary	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)
Secondary	The rate and type of adverse effects in the probiotic versus placebo groups		Until delivery (around 4 months)
Secondary	Number of urinary tract infections during the study period		Until delivery (around 4 months)