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

Probiotic Therapy in Pregnancy for the Reduction of Streptococcus Agalactiae Positivity and the Frequency of PROM, pPROM and Preterm Birth

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.

Study Overview

• Status: Completed
• Conditions: Genitourinary; Infection, Complicating Pregnancy
• Intervention / Treatment: Dietary supplement: Probiotic iNatal®

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 Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Perugia, Italy, 06122
    • Department of Obstetrics and Gynecology PERUGIA HOSPITAL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic supplement group; 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.	Dietary supplement: Probiotic iNatal®; iNatal® (Enterococcus faecium L3, Bifidobacterium animalis subsp. lactis BB-12, Lactococcus lactis SP38, Lacticaseibacillus casei R0215)
No Intervention: Control group; No probiotic supplementation. Participants in this group did not received probiotic iNatal® during 24-36 weeks of their gestation period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacteriological assessment	Control of bacteriuria by urine culture (number of participants)	12 weeks
Bacteriological assessment	Incidencce of Group B β-hemolytic streptococcus (GBS) infection positivity investigation by vaginal and/or rectal swab	12 weeks
Clinical assessments at the end of pregnancy	Incidence of Prelabor rupture of membranes (PROM)	12 weeks
Clinical assessments at the end of pregnancy	Incidence of Preterm PROM (PPROM)	12 weeks
Clinical assessments at the end of pregnancy	Incidence of Preterm birth	12 weeks
clinical assessments at the end of pregnancy	Rate of natural or caesarean section mode	12 weeks
Clinical assessments at the end of pregnancy	Incidence of induction of child birth	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of incidence of side effects	Number of participants presenting any side effects	12 weeks

Collaborators and Investigators

• Sponsor: Liaquat University of Medical & Health Sciences
• Collaborators: Università degli Studi dell'Insubria

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: January 20, 2024
• First Submitted That Met QC Criteria: January 20, 2024
• First Posted (Actual): January 30, 2024

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 20, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Infections; Pregnancy Complications
• Other Study ID Numbers: LUMHS/iNatal/20.01.2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No