Clinical trial NCT06231056: Probiotic Supplementation as Prophylactic for Group B β-hemolytic Streptococcus (GBS) Infection
Official title: Probiotic Therapy in Pregnancy for the Reduction of Streptococcus Agalactiae Positivity and the Frequency of PROM, pPROM and Preterm Birth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Genitourinary; Infection, Complicating Pregnancy
Lead sponsor: Liaquat University of Medical & Health Sciences
Sponsor class: OTHER
Collaborators: name: Università degli Studi dell'Insubria
First posted: 2024-01-30
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Probiotic supplement group
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Bacteriological assessment
timeFrame: 12 weeks
measure: Bacteriological assessment
timeFrame: 12 weeks
measure: Clinical assessments at the end of pregnancy
timeFrame: 12 weeks
measure: Clinical assessments at the end of pregnancy
timeFrame: 12 weeks
measure: Clinical assessments at the end of pregnancy
timeFrame: 12 weeks
measure: clinical assessments at the end of pregnancy
timeFrame: 12 weeks
measure: Clinical assessments at the end of pregnancy
timeFrame: 12 weeks
Secondary outcomes:
measure: Rate of incidence of side effects
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Perugia
country: Italy
facility: Department of Obstetrics and Gynecology PERUGIA HOSPITAL
Study officials:
References: