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.
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
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
250
iNatal® (Enterococcus faecium L3, Bifidobacterium animalis subsp. lactis BB-12, Lactococcus lactis SP38, Lacticaseibacillus casei R0215)
Department of Obstetrics and Gynecology PERUGIA HOSPITAL
Perugia, Italy
Bacteriological assessment
Control of bacteriuria by urine culture (number of participants)
Time frame: 12 weeks
Bacteriological assessment
Incidencce of Group B β-hemolytic streptococcus (GBS) infection positivity investigation by vaginal and/or rectal swab
Time frame: 12 weeks
Clinical assessments at the end of pregnancy
Incidence of Prelabor rupture of membranes (PROM)
Time frame: 12 weeks
Clinical assessments at the end of pregnancy
Incidence of Preterm PROM (PPROM)
Time frame: 12 weeks
Clinical assessments at the end of pregnancy
Incidence of Preterm birth
Time frame: 12 weeks
clinical assessments at the end of pregnancy
Rate of natural or caesarean section mode
Time frame: 12 weeks
Clinical assessments at the end of pregnancy
Incidence of induction of child birth
Time frame: 12 weeks
Rate of incidence of side effects
Number of participants presenting any side effects
Time frame: 12 weeks
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