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

NCT ID: NCT02795845

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2021-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bacterial Vaginosis and Vaginal Candidiasis At Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Primary prevention- probiotic capsules

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.

Group Type EXPERIMENTAL

Probiotic Capsule containing L. acidophilus, L. Paracasei, L. Rhamnosus, streptococcus thermophilus and Bifidobacterium bifidum

Intervention Type DIETARY_SUPPLEMENT

Probiotic

Primary prevention - Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

capsule without active ingredient

Secondary prevention - 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 probiotic capsules.

Group Type EXPERIMENTAL

Probiotic Capsule containing L. acidophilus, L. Paracasei, L. Rhamnosus, streptococcus thermophilus and Bifidobacterium bifidum

Intervention Type DIETARY_SUPPLEMENT

Probiotic

Secondary prevention - 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 placebo without active ingredient.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

capsule without active ingredient

Interventions

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Probiotic Capsule containing L. acidophilus, L. Paracasei, L. Rhamnosus, streptococcus thermophilus and Bifidobacterium bifidum

Probiotic

Intervention Type DIETARY_SUPPLEMENT

Placebo

capsule without active ingredient

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Departement of obstetric and gynecology, HaEmek medical center

Afula, , Israel

Site Status

Women Helth center - Clalit

Afula, , Israel

Site Status

The holy family hospital

Nazareth, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0079-15

Identifier Type: -

Identifier Source: org_study_id