Role of Oral Lactobacilli on Vaginal Flora of Pregnant Women

NCT04638257 | Completed Phase 1

• 1 other identifier: 12-239
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bacterial Vaginosis

Outcome Measures

Primary Outcomes (1)

• 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.

  Pregnancy (<18 weeks gestation) for 60 days

Secondary Outcomes (3)

• Number of participants with incidence and severity of Bacterial Vaginosis during pregnancy assessing for positive lab results screening for Bacterial Vaginiosis

  baseline up until 8 (after starting the study drug)

• Number of Preterm deliveries

  baseline up until 36 weeks gestation

• Measure the inflammatory markers in the vaginal secretions

  baseline up until 8 (after starting the study drug)

Study Arms (2)

Lactobacilli

EXPERIMENTAL

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

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

Placebo

PLACEBO COMPARATOR

Receives placebo

Other: Placebo

Interventions

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

Daily oral Lactobacilli starting at =\<18 weeks of gestation in singleton pregnancy

Lactobacilli

Placebo OTHER

Daily oral placebo starting at =\<18 weeks of gestation in singleton pregnancy

Placebo

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

MeSH Terms

Conditions

Vaginosis, Bacterial

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

Study Officials

• Sunil K Jain, MD

  The University of Texas Medical Branch, Galveston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2015
• First Posted: November 20, 2020
• Study Start: January 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: November 20, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share