NCT05156333

Probiotics and GBS Colonization in Pregnancy

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

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 402 (estimated)
• Sponsor: University of Modena and Reggio Emilia · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• GBS Rectovaginal Colonization
• Neonatal Sepsis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Respecta	Respecta® complex (mixture of probiotics and milk glycoproteins with prebiotic action); Cornstarch; Anti-caking agents: Vegetable magnesium stearate, Silicon dioxide; Capsule orally administered: Hydroxypropylmethylcellulose (coloring: E171). 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.

Timeline

• Start date: 2020-10-15
• Primary completion: 2022-09-30
• Completion: 2022-12-31
• First posted: 2021-12-14
• Last updated: 2022-11-07

Locations

3 sites across 1 country: Italy