Bacterial Vaginosis and Vaginal Candidiasis At PregnancyNCT02795845
Oral Probiotics for the Treatment and Prevention of Vulvovaginal Infections in Pregnancy - Double-blind, Randomized, Placebo-controlled Study
A study testing Probiotic Capsule containing L. acidophilus, L. Paracasei, L. Rhamnosus, streptococcus thermophilus and Bifidobacterium bifidum in people with Bacterial Vaginosis and Vaginal Candidiasis At Pregnancy, run by HaEmek Medical Center, Israel at 3 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bacterial Vaginosis and Vaginal Candidiasis At Pregnancy
- What is being tested?
- Probiotic Capsule containing L. acidophilus, L. Paracasei, L. Rhamnosus, streptococcus thermophilus and Bifidobacterium bifidum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 3 sitesIsrael
- Study dates
- Nov 2016to Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Departement of obstetric and gynecology, HaEmek medical center
Afula
Women Helth center - Clalit
Afula
The holy family hospital
Nazareth
About this study
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.
Read the detailed description
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.
- Being tested
- Probiotic Capsule containing L. acidophilus, L. Paracasei, L. Rhamnosus, streptococcus thermophilus and Bifidobacterium bifidum, Placebo
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Capsule containing L. acidophilus, L. Paracasei, L. Rhamnosus, streptococcus thermophilus and Bifidobacterium bifidumDietary supplement
Probiotic
PlaceboOther
capsule without active ingredient
| Study group | Role | What they receive |
|---|---|---|
| Primary prevention- probiotic capsules | Experimental | 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. Receives: Dietary Supplement: Probiotic Capsule containing L. acidophilus, L. Paracasei, L. Rhamnosus, streptococcus thermophilus and Bifidobacterium bifidum |
| Primary prevention - Placebo | Placebo comparator | 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. Receives: Other: Placebo |
| Secondary prevention - probiotic capsules | Experimental | 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. Receives: Dietary Supplement: Probiotic Capsule containing L. acidophilus, L. Paracasei, L. Rhamnosus, streptococcus thermophilus and Bifidobacterium bifidum |
| Secondary prevention - Placebo | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Until delivery (around 4 months)
Secondary outcomes (10)
Duration of time from the beginning of the study until an episode of vaginal infection (either AVF/BV or VVC).
Measured: From randomization until delivery (around 4 months)
The number of episodes of vaginal infections during pregnancy (either AVF/BV or VVC).
Measured: 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
Measured: From randomization until delivery (around 4 months)
The rate and type of adverse effects in the probiotic versus placebo groups (e.g gastrointestinal symptoms).
Measured: From randomization until two weeks after delivery (around 4 months)
Number of urinary tract infections during the study period
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From randomization until delivery (around 4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startNov 2016
- Primary completionJul 2021
- Study completionAug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial Vaginosis and Vaginal Candidiasis At PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02795845
- Sponsor's protocol ID
- 0079-15
- Status last verified
- Aug 2021
- First submitted
- 7 Jun 2016
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Probiotics for the Treatment and Prevention of Vulvovaginal Infections in Pregnancy - Double-blind, Randomized, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT02795845
- Acronym / sponsor ID
- 0079-15
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Jul 2021 (actual)
- Study completion
- Aug 2021 (actual)
- First posted
- 10 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Primary prevention- probiotic capsules | Experimental | Dietary Supplement: Probiotic Capsule containing L. acidophilus, L. Paracasei, L. Rhamnosus, streptococcus thermophilus and Bifidobacterium bifidumpatients 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. |
| Primary prevention - Placebo | Placebo comparator | Other: Placebopatients with normal vaginal flora in the placebo arm will be treated with a capsule without active ingredient, one capsule twice a day until delivery. |
| Secondary prevention - probiotic capsules | Experimental | Dietary Supplement: Probiotic Capsule containing L. acidophilus, L. Paracasei, L. Rhamnosus, streptococcus thermophilus and Bifidobacterium bifidumPatients 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. |
| Secondary prevention - Placebo | Placebo comparator | Other: PlaceboPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic Capsule containing L. acidophilus, L. Paracasei, L. Rhamnosus, streptococcus thermophilus and Bifidobacterium bifidumProbiotic | Dietary supplement | Primary prevention- probiotic capsules, Secondary prevention - probiotic capsules |
| Placebocapsule without active ingredient | Other | Primary prevention - Placebo, Secondary prevention - Placebo |
Primary outcome
The degree of vaginal lactobacilli colonization in the probiotic formula group versus placebo
Time frame: Around 4 months
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.
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)
10 secondary outcomes
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
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Capsule containing L. acidophilus, L. Paracasei, L. Rhamnosus, streptococcus thermophilus and Bifidobacterium bifidum in people with Bacterial Vaginosis and Vaginal Candidiasis At Pregnancy, run by HaEmek Medical Center, Israel at 3 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The degree of vaginal lactobacilli colonization in the probiotic formula group versus placebo (time frame: Around 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.