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

Not Applicable

Completed

• Conditions: Genitourinary; Infection, Complicating Pregnancy
• Interventions: Dietary Supplement: Probiotic iNatal®

• Registration Number: NCT06231056
• Lead Sponsor: Liaquat University of Medical & Health Sciences

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2023-06-30
• Status Verified: 2024-01
• Study First Submitted: 2024-01-20
• Study First Submitted QC: 2024-01-20
• Last Update Submitted: 2024-01-20
• Study First Posted: 2024-01-30
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic supplement group	Probiotic iNatal®	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.

Primary Outcome Measures

Name	Time	Method
Clinical assessments at the end of pregnancy	12 weeks	Incidence of induction of child birth
clinical assessments at the end of pregnancy	12 weeks	Rate of natural or caesarean section mode
Bacteriological assessment	12 weeks	Incidencce of Group B β-hemolytic streptococcus (GBS) infection positivity investigation by vaginal and/or rectal swab

Secondary Outcome Measures

Name	Time	Method
Rate of incidence of side effects	12 weeks	Number of participants presenting any side effects

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology PERUGIA HOSPITAL; 🇮🇹 Perugia, Italy