NCT03669094: PROBIGEST

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

Completed NA Last updated 3 March 2022

What this trial tests

NA trial testing Lactobacillus salivarius V4II-90 in Gestational Mother in 40 participants. Completed in 4 October 2021.

Timeline

5 December 2018

Primary endpoint
2 August 2021

4 October 2021

Quick facts

Lead sponsor	ProbiSearch SL
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	40
Start date	5 December 2018
Primary completion	2 August 2021
Estimated completion	4 October 2021
Sites	1 location across Spain

Drugs / interventions tested

• Lactobacillus salivarius V4II-90
• Placebo

Conditions studied

• Gestational Mother — all drugs for Gestational Mother →
• Streptococcus Agalactiae Infection — all drugs for Streptococcus Agalactiae Infection →

Sponsor

ProbiSearch SL — full company profile →

Who can join

Adults 18 to 45, female only, with Gestational Mother or Streptococcus Agalactiae Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interaction Between Microbiota and Immunity: Molecular Mechanisms, Biological Functions, Diseases, and New Therapeutic Opportunities.
   Zeng J, He Z, Wang G, Ma Y, et al · · 2025 · cited 5× · PMID 40547945 · DOI 10.1002/mco2.70265
2. Ligilactobacillus salivarius V4II-90 eradicates Group B Streptococcus colonisation during pregnancy: a randomised, double-blind, placebo-controlled trial.
   Gálvez A, Dı Az de Terán E, Espinosa JÁ, Pérez-Pedregosa J, et al · · 2024 · cited 2× · PMID 38955352 · DOI 10.1163/18762891-bja00021