Probiotics and GBS Colonization in Pregnancy

NASuspendedINTERVENTIONAL
Enrollment

402

Participants

Timeline

Start Date

October 15, 2020

Primary Completion Date

September 30, 2022

Study Completion Date

December 31, 2022

Conditions
GBS Rectovaginal ColonizationNeonatal Sepsis
Interventions
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."

Trial Locations (3)

20154

"Ospedale dei Bambini Vittore Buzzi", Milan

41124

University Hospital of Modena, Modena

42123

Arcispedale Santa Maria Nuova Reggio Emilia, Reggio Emilia

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Daniela Menichini

UNKNOWN

collaborator

Maria Longo

UNKNOWN

lead

University of Modena and Reggio Emilia

OTHER