An interventional study of Probiotic Capsule containing L. acidophilus, L. Paracasei, L. Rhamnosus, streptococcus thermophilus and Bifidobacterium bifidum and Placebo in Bacterial Vaginosis and Vaginal Candidiasis At Pregnancy, sponsored by HaEmek Medical Center, Israel. Completed at 3 sites in Israel. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-12.
Sponsored by HaEmek Medical Center, Israel · Not applicable, Interventional, and Treatment
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.
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 infections by migration of lactobacilli from the digestive system to the vagina in pregnant women.
Type of research and methods of data collection: randomized placebo-controlled trial.
Pregnant patients with symptoms consisted with vaginal infection will be examined and vaginal smear will be obtained, according to which the patients will be allocated to the following groups:
Primary prevention - women with normal vaginal flora Secondary prevention - women positive for AVF/BV and/or VVC- those women will be treated with antibiotic and/or antimycotic treatment. Following treatment, another smear will be taken to confirm infection eradication. If infection is still present, additional antibiotic and/or antimycotic treatment will be administered after which additional smear will be taken. Women with normal vaginal flora (after one of two treatments) will be recruited for the secondary prevention group.
In each group the patients will be divided into two subgroups, which will receive one capsule twice a day of either the Probiotic Femina ׀׀ capsules or placebo.
At the initial examination and once a month all the study groups will be tested for the presence of AVF/BV and candida. Additional vaginal samples will be taken to evaluate the presence of lactobacilli from the capsule and semi-quantitative assessment of vaginal lactobacilli.
228 studies on the registry are indexed under Vaginosis, Bacterial; 39 are open to participants now.
This study's enrollment of 157 is above the median of 100 across 194 interventional studies indexed under Vaginosis, Bacterial.
Browse Vaginosis, Bacterial studies →HaEmek Medical Center, Israel is the lead sponsor of 237 studies on the registry; 11 are open to participants now.
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Exclusion criteria:
patients with normal vaginal flora in the experimental arm will be treated with Probiotic capsules (containing L. acidophilus, L. Paracasei, L. Rhamnosus, streptococcus thermophilus, Bifidobacterium bifidum and B. Lactis). one capsule twice a day until delivery.
Dietary Supplement: Probiotic Capsule containing L. acidophilus, L. Paracasei, L. Rhamnosus, streptococcus thermophilus and Bifidobacterium bifidum
patients with normal vaginal flora in the placebo arm will be treated with a capsule without active ingredient, one capsule twice a day until delivery.
Other: Placebo
Patients with abnormal vaginal flora/bacterial vaginosis or vaginal candidiasis in the experimental arm will be treated with antibiotic (either clindamycin, metronidazole or both if necessary) or antimycotic treatment. Once the infection was eradicated, the patient will be given probiotic capsules.
Dietary Supplement: Probiotic Capsule containing L. acidophilus, L. Paracasei, L. Rhamnosus, streptococcus thermophilus and Bifidobacterium bifidum
Patients with abnormal vaginal flora/bacterial vaginosis or vaginal candidiasis in the experimental arm will be treated with antibiotic (either clindamycin, metronidazole or both if necessary) or antimycotic treatment. Once the infection was eradicated, the patient will be given placebo without active ingredient.
Other: Placebo
Probiotic
capsule without active ingredient
The degree of vaginal lactobacilli colonization in the probiotic formula group versus placebo
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.
Time frame: Around 4 months
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.
Time frame: From date of randomization until the date of first documented episode or until delivery (around 4 months)
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.
Time frame: Until delivery (around 4 months)
Duration of time from the beginning of the study until an episode of vaginal infection (either AVF/BV or VVC).
Time frame: From randomization until delivery (around 4 months)
The number of episodes of vaginal infections during pregnancy (either AVF/BV or VVC).
Time frame: From randomization until delivery (around 4 months)
The rate of women, who suffer from obstetrical complications
preterm labor, intrauterine growth restriction (IUGR), PPROM, chorioamnionitis, post-partum fever, post-partum endometritis
Time frame: From randomization until delivery (around 4 months)
The rate and type of adverse effects in the probiotic versus placebo groups (e.g gastrointestinal symptoms).
Time frame: From randomization until two weeks after delivery (around 4 months)
Number of urinary tract infections during the study period
Time frame: From randomization until delivery (around 4 months)
The rate of neonatal complications
Neonatal acute respiratory distress syndrome, intraventricular hemorrhage, neonatal sepsis, admission to the neonatal intensive care unit
Time frame: 30 days after delivery
The rate of women in the primary prevention group who developed AVF/BV during the study period until delivery in the probiotic formula group versus placebo.
Time frame: From randomization until delivery (around 4 months)
The rate of women in the primary prevention group who developed VVC during the study period until delivery in the probiotic formula group versus placebo.
Time frame: From randomization until delivery (around 4 months)
The rate of women in the second prevention group who developed AVF/BV during the study period until delivery in the probiotic formula group versus placebo.
Time frame: From randomization until delivery (around 4 months)
The rate of women in the second prevention group who developed VVC during the study period until delivery in the probiotic formula group versus placebo.
Time frame: From randomization until delivery (around 4 months)
Plan to share: No
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Ran from Nov 2016 to primary completion in Jul 2021, 56 months.
Of 30 non-industry interventional studies with no phase under Vaginosis, Bacterial, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 86. This study's 56 months is above that.
Counting every sponsor, half of 51 studies reached it within 12 months; a quarter within 5 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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HaEmek Medical Center, Israel →