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

NCT ID: NCT06231056

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2023-06-30

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.

Conditions

Genitourinary; Infection, Complicating Pregnancy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Probiotic supplement group

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.

Group Type: EXPERIMENTAL

Probiotic iNatal®

Intervention Type: DIETARY_SUPPLEMENT

iNatal® (Enterococcus faecium L3, Bifidobacterium animalis subsp. lactis BB-12, Lactococcus lactis SP38, Lacticaseibacillus casei R0215)

Control group

No probiotic supplementation. Participants in this group did not received probiotic iNatal® during 24-36 weeks of their gestation period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Probiotic iNatal®

iNatal® (Enterococcus faecium L3, Bifidobacterium animalis subsp. lactis BB-12, Lactococcus lactis SP38, Lacticaseibacillus casei R0215)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Università degli Studi dell'Insubria

OTHER

Sponsor Role: collaborator

Liaquat University of Medical & Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Dr. Amjad Khan

Professor of Clinical Biochemistry and Experimental Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Obstetrics and Gynecology PERUGIA HOSPITAL

Perugia, , Italy

Countries

Italy

Other Identifiers

LUMHS/iNatal/20.01.2024

Identifier Type: -

Identifier Source: org_study_id