Probiotics and GBS Colonization in Pregnancy

University of Modena and Reggio Emilia

Status: Suspended

Conditions: GBS Rectovaginal Colonization; Neonatal Sepsis

Treatments: Dietary Supplement: Respecta

Study type: Interventional

Funder types: Other

Identifiers

NCT05156333

AOU 0025949/19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 402 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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402 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Daily oral administration of 1 capusle of placebo, composed of: hydroxypropylmethylcellulose; Anti-caking agent: Magnesium salts of fatty acids, Dioxide of silicon; Dye: E171.

Treatment:

Dietary Supplement: Respecta

Probiotic

Active Comparator group

Description:

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).

Treatment:

Dietary Supplement: Respecta