Oral Probiotics for the Treatment and Prevention of Vulvovaginal Infections in Pregnancy - Double-blind, Randomized, Placebo-controlled Study
Bacterial Vaginosis and Vaginal Candidiasis at Pregnancy
About this trial
This is an interventional treatment trial for Bacterial Vaginosis and Vaginal Candidiasis at Pregnancy
Eligibility Criteria
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)
- Allergy to Fish (The capsules are manufactured in same line as Soy and fish therefore may contain those allergens)
- Women who take probiotic treatment orally or vaginally that refuse to discontinue treatment.
- Vaginal swab result suitable for study arm in which enrollment was completed
Sites / Locations
- Departement of obstetric and gynecology, HaEmek medical center
- Women Helth center - Clalit
- The holy family hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Primary prevention- probiotic capsules
Primary prevention - Placebo
Secondary prevention - probiotic capsules
Secondary prevention - Placebo
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.
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.
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.
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.