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

NCT03669094 | Completed

• 1 other identifier: STB/17.02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Participants (%) with a vaginal and/or rectal detection of Group B Streptococcus.

  Percentage of participants with a vaginal and/or rectal detection of Group B Streptococcus at the end of the study.

  6 months

Secondary Outcomes (8)

• Microbiota of vaginal exudates

  6 months

• Microbiota of rectal exudates

  6 months

• Premature membrane rupture

  7 months

• Premature detachment of the placenta

  7 months

• Premature delivery

  7 months

Study Arms (2)

L. salivarius V4II-90

ACTIVE COMPARATOR

Lactobacillus salivarius V4II-90; approximately 1\*10E9 colony forming unit (CFU) of L. salivarius V4II-90 in 1 oral capsule per day for 12 weeks.

Dietary Supplement: Lactobacillus salivarius V4II-90

Control group

PLACEBO COMPARATOR

Placebo supplement in 1 oral capsule per day for 12 weeks.

Dietary Supplement: Placebo

Interventions

Lactobacillus salivarius V4II-90 DIETARY_SUPPLEMENT

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.

L. salivarius V4II-90

Placebo DIETARY_SUPPLEMENT

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.

Control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy pregnant women, adults (≥ 18 years and under 45 years).
• Before/during week 13 of gestation.
• Signing of informed consent.

You may not qualify if:

• Multiple pregnancy.
• Fetal complications.
• History of premature delivery/miscarriage in the second trimester.
• Significant maternal medical complications.
• HIV-positive.
• Women who are immunocompromised (for example, patients with cancer and transplant who are taking certain immunosuppressive drugs, patients with hereditary diseases that affect or could affect the immune system).
• History of significant gastrointestinal disease (e.g., prior gastrointestinal resection, current diarrhea, inflammatory bowel disease).
• Heart failure and cardiac medical history (e.g. artificial heart valve, medical history of infective endocarditis, rheumatic fever or cardiac malformation).
• Use of other probiotics during the current pregnancy.
• Uncertainty of the investigator regarding the willingness or capacity of the participant to comply with the requirements of the protocol.

Sponsors & Collaborators

• ProbiSearch SL: lead
• Casen Recordati S.L.: collaborator

Study Sites (1)

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Related Publications (1)

• Galvez A, Di Az de Teran E, Espinosa JA, Perez-Pedregosa J, Bartha-Rasero JL, Del Valle JG, Cuerva MJ, Jimenez E, Badiola C. Ligilactobacillus salivarius V4II-90 eradicates Group B Streptococcus colonisation during pregnancy: a randomised, double-blind, placebo-controlled trial. Benef Microbes. 2024 Jun 28;15(4):387-396. doi: 10.1163/18762891-bja00021.

  PMID: 38955352 DERIVED

MeSH Terms

Conditions

Streptococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Susana Manzano, PhD

  ProbiSearch SL

  STUDY CHAIR

Study Design

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

Model Details: This is an interventional randomized, multicenter, double-blind, placebo-controlled, parallel-group study

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: September 13, 2018
• Study Start: December 5, 2018
• Primary Completion: August 2, 2021
• Study Completion: October 4, 2021
• Last Updated: March 3, 2022

Record last verified: 2022-03

Locations

ES (1)