Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-01 @ 9:36 AM
Study NCT ID:
NCT06231056
Status:
COMPLETED
Last Update Posted:
2024-01-30
First Post:
2024-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Probiotic Supplementation as Prophylactic for Group B β-hemolytic Streptococcus (GBS) Infection
Sponsor:
Liaquat University of Medical & Health Sciences
Organization:
Study Overview
Official Title:
Probiotic Therapy in Pregnancy for the Reduction of Streptococcus Agalactiae Positivity and the Frequency of PROM, pPROM and Preterm Birth
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: