Probiotic Supplementation as Prophylactic for Group B β-hemolytic Streptococcus (GBS) Infection

L

Liaquat University of Medical & Health Sciences

Status

Completed

Conditions

Genitourinary; Infection, Complicating Pregnancy

Treatments

Dietary Supplement: Probiotic iNatal®

Study type

Interventional

Funder types

Other

Identifiers

NCT06231056
LUMHS/iNatal/20.01.2024

Details and patient eligibility

About

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.

Full 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.

Enrollment

250 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

250 participants in 2 patient groups

Probiotic supplement group
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Probiotic iNatal®
Control group
No Intervention group
Description:
No probiotic supplementation. Participants in this group did not received probiotic iNatal® during 24-36 weeks of their gestation period.

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems