Probiotics and GBS Colonization in Pregnancy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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GBS Rectovaginal Colonization, Neonatal Sepsis

Intervention / Treatment
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* Dietary Supplement: Respecta


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicenter, prospective, randomized, placebo-controlled, double-blind, parallel-group study aimed at underestimating the feasibility and effect of the use of probiotic starting from week 30 on vaginal / rectal colonization of GBS in women at low obstetric risk.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Daily oral administration of 1 capusle of placebo, composed of: hydroxypropylmethylcellulose; Anti-caking agent: Magnesium salts of fatty acids, Dioxide of silicon; Dye: E171. | Dietary Supplement: Respecta<br>* 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.<br>* Other names: Probiotic;|
| Active Comparator: Probiotic<br>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). | Dietary Supplement: Respecta<br>* 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.<br>* Other names: Probiotic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GBS Rectovaginal colonization | Rate of colonized GBS pregnant (carriers) at the time of antepartum screening (35-37 ^ week). | at 35-37 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intrapartum antibiotics profilaxisi | Rata of women requiring antibiotic profilaxis intrapartum | during labor | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotics, Pregnancy, GBS colonization