Genitourinary; Infection, Complicating Pregnancy
Conditions
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
iNatal® (Enterococcus faecium L3, Bifidobacterium animalis subsp. lactis BB-12, Lactococcus lactis SP38, Lacticaseibacillus casei R0215)
Sponsors
Study design
Masking description
Control group
Intervention model description
Probiotic supplement group
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Bacteriological assessment | 12 weeks | Control of bacteriuria by urine culture (number of participants) |
| Clinical assessments at the end of pregnancy | 12 weeks | Incidence of Prelabor rupture of membranes (PROM) |
| clinical assessments at the end of pregnancy | 12 weeks | Rate of natural or caesarean section mode |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of incidence of side effects | 12 weeks | Number of participants presenting any side effects |
Countries
Italy