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| Name | Class |
|---|---|
| Università degli Studi dell'Insubria | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic supplement group | Experimental | 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. |
|
| Control group | No Intervention | No probiotic supplementation. Participants in this group did not received probiotic iNatal® during 24-36 weeks of their gestation period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic iNatal® | Dietary Supplement | iNatal® (Enterococcus faecium L3, Bifidobacterium animalis subsp. lactis BB-12, Lactococcus lactis SP38, Lacticaseibacillus casei R0215) |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of incidence of side effects | Number of participants presenting any side effects | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
The study is only applicable in pregnant female.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics and Gynecology PERUGIA HOSPITAL | Perugia | 06122 | Italy |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D011248 | Pregnancy Complications |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Probiotic supplement group
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Control group
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