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

NCT02795845 | Completed DMC

• 1 other identifier: 0079-15
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Bacterial Vaginosis and Vaginal Candidiasis At Pregnancy

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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).

  From randomization until delivery (around 4 months)

• The number of episodes of vaginal infections during pregnancy (either AVF/BV or VVC).

  From randomization until delivery (around 4 months)

• The rate of women, who suffer from obstetrical complications

  From randomization until delivery (around 4 months)

• The rate and type of adverse effects in the probiotic versus placebo groups (e.g gastrointestinal symptoms).

  From randomization until two weeks after delivery (around 4 months)

• Number of urinary tract infections during the study period

  From randomization until delivery (around 4 months)

Study Arms (4)

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.

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.

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.

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.

Other: Placebo

Interventions

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

Probiotic

Primary prevention- probiotic capsules; Secondary prevention - probiotic capsules

Placebo OTHER

capsule without active ingredient

Primary prevention - Placebo; Secondary prevention - Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (3)

Departement of obstetric and gynecology, HaEmek medical center

Afula, Israel

Location

Women Helth center - Clalit

Afula, Israel

Location

The holy family hospital

Nazareth, Israel

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2016
• First Posted: June 10, 2016
• Study Start: November 1, 2016
• Primary Completion: July 1, 2021
• Study Completion: August 1, 2021
• Last Updated: December 12, 2024

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (3)