MedTrace Logo

Effect of a New Probiotic Strain in the Reduction of Group B Streptococcus Colonization in Pregnant Women

NCT03669094 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-03-03

No results posted yet for this study

Summary

An interventional, randomized, multicenter, double-blind, placebo-controlled, parallel-group study will be conducted to evaluate the effectiveness of the strain Lactobacillus salivarius V4II-90 in the reduction of Group B Streptococcus (GBS) colonization in pregnant women who are GBS carriers. Forty GBS-positive participants in their first trimester of pregnancy will be randomly assigned to one of the two study groups: The experimental group with 3 months probiotic consumption; and the control group with 3 months placebo consumption. The efficacy of the probiotic strain to reduce the incidence of Group B Streptococcus will be assessed by the percentage of participants with a vaginal and/or rectal detection of Group B Streptococcus at the end of the study, by bilateral comparison of the treatment group with the control group at the same time period. The estimated duration of the study will be 30 weeks, which includes a 3-month product administration. The intervention will start at week 23 ± 4 days of pregnancy and end at week 35 ± 4 days. Then, a visit will be completed one month after delivery.

Conditions

  • Gestational Mother
  • Streptococcus Agalactiae Infection

Interventions

DIETARY_SUPPLEMENT

Lactobacillus salivarius V4II-90

7 months intervention study: with a screening period of 12 weeks after which participants GBS+ women will be randomized and start the orally intake of 1 capsule per day of the Lactobacillus salivarius V4II-90 (1\*10E9 CFU) probiotic supplement over a 12 weeks period. A visit will then be completed one month after delivery.

DIETARY_SUPPLEMENT

Placebo

7 months intervention study: with a screening period of 12 weeks after which participants GBS+ women will be randomized and start the orally intake of 1 capsule per day of the placebo supplement over a 12 weeks period. A visit will then be completed one month after delivery.

Sponsors & Collaborators

  • Casen Recordati S.L.

    collaborator INDUSTRY

  • ProbiSearch SL

    lead INDUSTRY

Principal Investigators

  • Susana Manzano, PhD · ProbiSearch SL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-05
Primary Completion
2021-08-02
Completion
2021-10-04

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03669094 on ClinicalTrials.gov