Oral Probiotics for the Treatment and Prevention of Vulvovaginal Infections in Pregnancy - Double… (NCT02795845) | Clinical Trial Compass
CompletedNot Applicable
Oral Probiotics for the Treatment and Prevention of Vulvovaginal Infections in Pregnancy - Double-blind, Randomized, Placebo-controlled Study
Israel157 participantsStarted 2016-11
Plain-language 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. In the present study we will examine if oral probiotics are effective in prevention of vaginal infections by migration of lactobacilli from the digestive system to the vagina in pregnant women.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Women who will report on vaginal discharge or signs/symptoms consistent with vaginal/vulvar infection
✓. Above 18 years old
✓. pregnant women until 30th weeks of gestation
✓. Willing to participate and singed on consent form
Exclusion criteria
✕. Patient refuse to participate in the study
✕. Women with preterm premature rupture of the membranes (at enrollment)
✕. Immunocompromised women (e.g. autoimmune diseases treated medically)
✕. Failure to eradicate BV/AVF and/or VVC after 2 treatment cycles
✕. Trichomonas infection at enrollment
✕. Allergy to Soy (The capsules are manufactured in same line as Soy and fish therefore may contain those allergens)
What they're measuring
1
The degree of vaginal lactobacilli colonization in the probiotic formula group versus placebo
Timeframe: Around 4 months
2
The rate of women in the primary prevention group, who developed any vaginal infection (BV/AVF/VVC) during the study period until delivery in the probiotic formula group versus placebo.
Timeframe: From date of randomization until the date of first documented episode or until delivery (around 4 months)
3
The rate of women in the second prevention group who developed any vaginal infection (BV/AVF/VVC) during the study period until delivery in the probiotic formula group versus placebo.