Probiotic Supplementation as Prophylactic for Group B β-hemolytic Streptococcus (GBS) Infection

Liaquat University of Medical & Health Sciences

Status: Completed

Conditions: Genitourinary; Infection, Complicating Pregnancy

Treatments: Dietary Supplement: Probiotic iNatal®

Study type: Interventional

Funder types: Other

Identifiers

NCT06231056

LUMHS/iNatal/20.01.2024

Details and patient eligibility

About

Streptococcus agalactiae, a Group B β-hemolytic streptococcus (GBS), is the leading cause of severe neonatal infection in developed countries. There is growing scientific interest in probiotic supplementation in pregnancy as possible prophylaxis for GBS infections and urine culture positivity.

Full description

There is strong scientific evidence that supports the correlation between bacterial vaginosis (BV), a term used to define a change in the vaginal ecosystem, and spontaneous preterm birth. Antibiotic treatments are recommended to counteract both the presence of S. agalactiae and the onset of BV. The latter, however, are not without risks, as they can in turn cause alterations in the vaginal microbiota and is associated with an increased risk of miscarriage.

Recent research have shown that probiotic treatment can help reduc the risk of preterm birth and positivity of Group B β-hemolytic streptococcus (GBS) infection.

The present study aimed to assess the efficacy and safety of a probiotic iNatal® (probiotic mixture containing 10 ml CFU of Enterococcus faecium L3, 3 billion CFU of Bifidobacterium animalis subsp. lactis BB-12, 3 billion CFU of Lactococcus lactis SP38, 3 billion CFU of Lacticaseibacillus casei R0215) in pregnant wemen in 24 to 36 weeks of gestation as prophylaxis of GBS infections and urine culture positivity.

This was a retrospective, observational, controlled and single centre study.

Enrollment: 250 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant women in 24-36 weeks of gestation period
• History of recurrent genitourinary and/or intestinal problems

Exclusion criteria

• Presence of neurological condition
• History of cardiovascular disease
• History of pulmonary disease
• History of renal disease
• Cancer

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Probiotic supplement group

Experimental group

Description:

Participants in this group received probiotic iNatal® (Enterococcus faecium L3, Bifidobacterium animalis subsp. lactis BB-12, Lactococcus lactis SP38, Lacticaseibacillus casei R0215) - dosage 1 sachet per day, during the 24-36 weeks of their gestation period.

Treatment:

Dietary Supplement: Probiotic iNatal®

Control group

No Intervention group

Description:

No probiotic supplementation. Participants in this group did not received probiotic iNatal® during 24-36 weeks of their gestation period.