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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06231056
Enrollment
250
Registered
2024-01-30
Start date
2019-01-01
Completion date
2023-06-30
Last updated
2024-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genitourinary; Infection, Complicating Pregnancy

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.

Interventions

DIETARY_SUPPLEMENTProbiotic iNatal®

iNatal® (Enterococcus faecium L3, Bifidobacterium animalis subsp. lactis BB-12, Lactococcus lactis SP38, Lacticaseibacillus casei R0215)

Sponsors

Università degli Studi dell'Insubria
CollaboratorOTHER
Liaquat University of Medical & Health Sciences
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Masking description

Control group

Intervention model description

Probiotic supplement group

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Bacteriological assessment12 weeksControl of bacteriuria by urine culture (number of participants)
Clinical assessments at the end of pregnancy12 weeksIncidence of Prelabor rupture of membranes (PROM)
clinical assessments at the end of pregnancy12 weeksRate of natural or caesarean section mode

Secondary

MeasureTime frameDescription
Rate of incidence of side effects12 weeksNumber of participants presenting any side effects

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026