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

HaEmek Medical Center, Israel

Status: Terminated

Conditions: Pregnancy

Treatments: Other: Placebo; Dietary Supplement: Probotic capsule containing L. rhamnosus GR-1and L. reuteri RC-14; Dietary Supplement: Urex Plus

Study type: Interventional

Funder types: Other

Identifiers

NCT02430246

0096-13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 8 patient groups, including a placebo group

Primary prevention - Urex Plus

Experimental group

Description:

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

Treatment:

Dietary Supplement: Urex Plus

Primary prevention - Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo

Secondary prevention - Urex Plus

Experimental group

Description:

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

Treatment:

Dietary Supplement: Urex Plus

Secondary prevention - Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo

Eradication - Urex Plus

Experimental group

Description:

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

Treatment:

Dietary Supplement: Urex Plus

Eradication - Placebo

Placebo Comparator group

Description:

Patients with persistent abnormal vaginal flora following treatment with clindamycin and metronidazole in the placebo arm will be treated with placebo without active ingredient

Treatment:

Other: Placebo

Lactobacilli transfer - probiotic capsule

Other group

Description:

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

Treatment:

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

Lactobacilli transfer - probiotic capsule after 2 months

Other group

Description:

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.

Treatment:

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