Probiotics and GBS Colonization in Pregnancy

Neonatal Sepsis Clinical Trial

Official title: Probiotics in Pregnancy and Rectovaginal Group B Streptococcus (GBS) Colonization

Status Suspended

Clinical Trial Summary

Multicentric, randomized, placebo-controlled, double-blind, parallel group study aimed at evaluating the feasibility and effect of the use of probiotic starting from the 30th week, on vaginal / rectal colonization of GBS in women at low obstetric risk.

Clinical Trial Description

Multicenter, randomized, placebo-controlled, double-blind, parallel group study aimed at evaluating the feasibility and effect of the use of probiotic starting from the 30th week, on vaginal / rectal colonization of GBS in women at low obstetric risk.

The study includes low obstetric risk pregnant women within the 33rd week of gestation, with vaginal delivery expected. It excludes women who during pregnancy had a positive urine culture for GBS, women with a previous newborn suffering from early sepsis, use of antibiotics in the month prior to enrollment, women unable to understand the study and sign informed consent.

Intervention Daily oral administration of two capsules of the Giellepi Spa class IIa medical device "Respecta" or placebo, to be taken with a glass of water preferably between meals, starting from the 30th week of pregnancy until the 37th week after having vagino-rectal swab screening performed. ;

Related Conditions & MeSH terms

• Neonatal Sepsis

• NCT number: NCT05156333
• Study type: Interventional
• Source: University of Modena and Reggio Emilia
• Status: Suspended
• Phase: N/A
• Start date: October 15, 2020
• Completion date: December 31, 2022