Oral Probiotics for the Treatment and Prevention of Vulvovaginal Infections in Pregnancy - Double-blind, Randomized, Placebo-controlled Study

Launched by HAEMEK MEDICAL CENTER, ISRAEL · Jun 7, 2016

Keywords

ClinConnect Summary

During pregnancy, bacterial vaginosis (BV), abnormal vaginal flora (AVF) and vulvovaginal candidiasis (VVC) are associated with serious complications and discomfort. Yet, treatment options are limited. Lactobacilli administration was suggested to treat and prevent vaginal infections. However, this has not been examined in pregnant women, the information regarding oral treatment is scarce, and the mechanisms in which oral ingestion of probiotics induce vaginal lactobacilli proliferation are not well established.

Working hypothesis: Oral probiotics will be effective in prevention of vaginal ...

Gender

FEMALE

Eligibility criteria

• Inclusion criteria:
• • 1. Women who will report on vaginal discharge or signs/symptoms consistent with vaginal/vulvar infection
• • 2. Above 18 years old
• • 3. pregnant women until 30th weeks of gestation
• • 4. Willing to participate and singed on consent form
• Exclusion criteria:
• • 1. Patient refuse to participate in the study
• • 2. Women with preterm premature rupture of the membranes (at enrollment)
• • 3. Immunocompromised women (e.g. autoimmune diseases treated medically)
• • 4. Failure to eradicate BV/AVF and/or VVC after 2 treatment cycles
• • 5. Trichomonas infection at enrollment
• • 6. Allergy to Soy (The capsules are manufactured in same line as Soy and fish therefore may contain those allergens)
• • 7. Allergy to Fish (The capsules are manufactured in same line as Soy and fish therefore may contain those allergens)
• • 8. Women who take probiotic treatment orally or vaginally that refuse to discontinue treatment.
• • 9. Vaginal swab result suitable for study arm in which enrollment was completed