Probiotics and GBS Colonization in Pregnancy

Not Applicable

Suspended

• Conditions: GBS Rectovaginal Colonization; Neonatal Sepsis
• Interventions: Dietary Supplement: Respecta

• Registration Number: NCT05156333
• Lead Sponsor: University of Modena and Reggio Emilia

Brief 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.

Study Timeline

• Study Start: 2020-10-15
• Study First Submitted: 2021-10-05
• Study First Submitted QC: 2021-12-13
• Study First Posted: 2021-12-14
• Primary Completion: 2022-09-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-07
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: 402

Inclusion Criteria

• low obstetric risk pregnant women by the 33rd week of gestation,
• vaginal delivery expected.

Exclusion Criteria

• positive urine culture for GBS,
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Respecta	Daily oral administration of 1 capusle of placebo, composed of: hydroxypropylmethylcellulose; Anti-caking agent: Magnesium salts of fatty acids, Dioxide of silicon; Dye: E171.
Probiotic	Respecta	Daily oral administration of 1 capsule of mixture of probiotics and milk glycoproteins with prebiotic action); Cornstarch; Anti-caking agents: Vegetable magnesium stearate, Silicon dioxide; Capsule orally administered: Hydroxypropylmethylcellulose (coloring: E171).

Primary Outcome Measures

Name	Time	Method
GBS Rectovaginal colonization	at 35-37 weeks	Rate of colonized GBS pregnant (carriers) at the time of antepartum screening (35-37 \^ week).

Secondary Outcome Measures

Name	Time	Method
Intrapartum antibiotics profilaxisi	during labor	Rata of women requiring antibiotic profilaxis intrapartum

Trial Locations

Locations (3)

Arcispedale Santa Maria Nuova Reggio Emilia; 🇮🇹 Reggio Emilia, RE, Italy

University Hospital of Modena; 🇮🇹 Modena, Italy

Ospedale dei Bambini "Vittore Buzzi"; 🇮🇹 Milan, MI, Italy