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Role of Oral Lactobacilli on Vaginal Flora of Pregnant Women

Primary Purpose

Bacterial Vaginosis

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Lactobacilli rhamnosus GR-1 and Lactobacilli fermentum RC-14
Placebo
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Vaginosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Pregnant women <18 weeks gestational age
  2. >18 years old and able provide informed consent
  3. No clinical bacterial vaginosis requiring anti-microbial treatment
  4. BV Blue test positive on screening
  5. Planned or probable delivery at UTMB, Galveston

Exclusion Criteria:

  1. Taking antibiotics or any other microbial at the time of recruitment
  2. Documented need for cervical cerclage
  3. Multi fetal pregnancy
  4. Known aneuploidy or lethal fetal anomalies
  5. Illicit drug use
  6. Serious maternal medical conditions

    1. Renal insufficiency with serum creatinine >1.5, known proteinuria >300mg/24 hours or receiving dialysis.
    2. Chronic liver disease with liver transaminases >2 times the upper limit of the normal range
    3. Organ transplant recipients.
    4. Severe pulmonary disorder (such as significant obstructive/restrictive disorder, pulmonary hypertension, cystic fibrosis, and chronic oxygen requirement).
    5. Severe heart disease (such as cardiomyopathy with decreased left ventricular ejection fraction, obstructive valvular disease, replaced heart valve, uncorrected aortic coarctation or tetrology).
    6. Established lupus anticoagulant syndrome or antiphospholipid syndrome).
    7. Diabetes class C and greater
    8. Chronic conditions requiring medications for control (such as chronic hypertension, SLE, inflammatory bowel disease, and asthma).
    9. Acquired Immunodeficiency Syndrome or HIV infection without AIDS.
  7. Medical complications of pregnancy

    1. Pre-eclampsia
    2. Thrombophilia
    3. Pregnancy induced hypertension
    4. Gestational diabetes

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Lactobacilli

    Placebo

    Arm Description

    Lactobacilli rhamnosus GR-1 and Lactobacilli fermentum RC-14 Lactobacilli rhamnosus GR-1 and Lactobacilli fermentum RC-14

    Receives placebo

    Outcomes

    Primary Outcome Measures

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
    This number will determine if oral supplementation of lactobacilli is safe and tolerated by pregnant women.

    Secondary Outcome Measures

    Number of participants with incidence and severity of Bacterial Vaginosis during pregnancy assessing for positive lab results screening for Bacterial Vaginiosis
    BV Blue test Nugent scoring Amsel clinical criteria
    Number of Preterm deliveries
    Preterm delivery (<37 weeks gestation)
    Measure the inflammatory markers in the vaginal secretions
    IL1β IL6 IL8 TNF-α GmCSF

    Full Information

    First Posted
    October 5, 2015
    Last Updated
    November 19, 2020
    Sponsor
    The University of Texas Medical Branch, Galveston
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04638257
    Brief Title
    Role of Oral Lactobacilli on Vaginal Flora of Pregnant Women
    Official Title
    A Phase I, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Effects of Probiotic Lactobacilli on Vaginal Flora of Pregnant Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2013 (undefined)
    Primary Completion Date
    March 2015 (Actual)
    Study Completion Date
    March 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The University of Texas Medical Branch, Galveston

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Bacterial vaginosis (BV) occurs in about 20% of pregnancies and responsible for up to 25% of visits to gynecological clinics. BV is characterized by a shift in vaginal bacterial flora from lactobacilli to pathogenic bacterial flora like Gardnerella and Mycoplasma. Risk factors for the development of BV include douching, use of intrauterine contraceptive devices, new or multiple sexual partners, smoking and African American background.
    Detailed Description
    Diagnosis of BV based on Amsel's criteria and Nugent's scoring. In Amsel's criteria include: presence of thin vaginal discharge, clue cells, vaginal fluid pH >4.5 and positive whiff test. The Nugent score is derived from gram-stained vaginal smear; yielding a score between 0 - 10. A score of, 4 is normal, 4 - 6 is intermediate and a score >7 represents BV. CDC recommends diagnosis of BV on the presence of >3 Amsel criteria and a Nugent score >7. FDA recommends, verification of BV cure should be conducted 21 - 30 days after the initiation of therapy (absence of Amsel's criteria and Nugent score <4). Cure rate of BV with conventional anti-microbial agents have been disappointing due to high recurrence rate of BV. Recurrence of BV results in repeated exposure to anti-microbial agents which may lead to emergence of drug-resistance strains & the potential for adverse reactions. This suggests a need for alternative therapeutic measures of BV. Lactobacilli rhamnosus GR-1 and Lactobacilli fermentum RC-14 are H2O2 producing lactobacilli which are toxic to bacteria causing BV by antagonizing the growth and adhesion of pathologic bacteria causing BV. In non-pregnant women, oral administrations of these strains of lactobacilli are safe, and reduce the risk of BV by restoring predominant lactobacilli, the normal vaginal bacterial flora. Bacterial vaginosis is associated with increased incidence of preterm delivery. For pregnant women, restoration of lactobacilli in the genital tract could be very important to prevent BV and may lower the risk of preterm labor. At present, the safety, tolerability and efficacy of lactobacilli use during pregnancy is not well known for the fetus and the pregnant women. The investigators plan to do a phase I trial to evaluate the safety, tolerability, and efficacy of oral lactobacilli on vaginal flora of pregnant women and follow up their infants for any side effect up to 6 months of age. In summary, treatment failure and recurrence of BV following anti-microbial treatment is frustrating. During pregnancy, probiotics may be the next step to treat BV and restore normal vaginal micro flora. But the safety of lactobacilli use during pregnancy is not established. The investigators will do phase I trial to evaluate safety of oral lactobacilli in pregnant women along with their infants up to 6 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bacterial Vaginosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    49 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lactobacilli
    Arm Type
    Experimental
    Arm Description
    Lactobacilli rhamnosus GR-1 and Lactobacilli fermentum RC-14 Lactobacilli rhamnosus GR-1 and Lactobacilli fermentum RC-14
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Receives placebo
    Intervention Type
    Biological
    Intervention Name(s)
    Lactobacilli rhamnosus GR-1 and Lactobacilli fermentum RC-14
    Intervention Description
    Daily oral Lactobacilli starting at =<18 weeks of gestation in singleton pregnancy
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Daily oral placebo starting at =<18 weeks of gestation in singleton pregnancy
    Primary Outcome Measure Information:
    Title
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
    Description
    This number will determine if oral supplementation of lactobacilli is safe and tolerated by pregnant women.
    Time Frame
    Pregnancy (<18 weeks gestation) for 60 days
    Secondary Outcome Measure Information:
    Title
    Number of participants with incidence and severity of Bacterial Vaginosis during pregnancy assessing for positive lab results screening for Bacterial Vaginiosis
    Description
    BV Blue test Nugent scoring Amsel clinical criteria
    Time Frame
    baseline up until 8 (after starting the study drug)
    Title
    Number of Preterm deliveries
    Description
    Preterm delivery (<37 weeks gestation)
    Time Frame
    baseline up until 36 weeks gestation
    Title
    Measure the inflammatory markers in the vaginal secretions
    Description
    IL1β IL6 IL8 TNF-α GmCSF
    Time Frame
    baseline up until 8 (after starting the study drug)

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Pregnant women <18 weeks gestational age >18 years old and able provide informed consent No clinical bacterial vaginosis requiring anti-microbial treatment BV Blue test positive on screening Planned or probable delivery at UTMB, Galveston Exclusion Criteria: Taking antibiotics or any other microbial at the time of recruitment Documented need for cervical cerclage Multi fetal pregnancy Known aneuploidy or lethal fetal anomalies Illicit drug use Serious maternal medical conditions Renal insufficiency with serum creatinine >1.5, known proteinuria >300mg/24 hours or receiving dialysis. Chronic liver disease with liver transaminases >2 times the upper limit of the normal range Organ transplant recipients. Severe pulmonary disorder (such as significant obstructive/restrictive disorder, pulmonary hypertension, cystic fibrosis, and chronic oxygen requirement). Severe heart disease (such as cardiomyopathy with decreased left ventricular ejection fraction, obstructive valvular disease, replaced heart valve, uncorrected aortic coarctation or tetrology). Established lupus anticoagulant syndrome or antiphospholipid syndrome). Diabetes class C and greater Chronic conditions requiring medications for control (such as chronic hypertension, SLE, inflammatory bowel disease, and asthma). Acquired Immunodeficiency Syndrome or HIV infection without AIDS. Medical complications of pregnancy Pre-eclampsia Thrombophilia Pregnancy induced hypertension Gestational diabetes
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sunil K Jain, MD
    Organizational Affiliation
    University of Texas Medical Branch at Galveston
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Role of Oral Lactobacilli on Vaginal Flora of Pregnant Women

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