Probiotics and GBS Colonization in Pregnancy

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

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.

Study Overview

• Status: Suspended
• Conditions: Neonatal Sepsis; GBS Rectovaginal Colonization
• Intervention / Treatment: Dietary supplement: Respecta

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 Type: Interventional
• Enrollment (Anticipated): 402
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Modena, Italy, 41124
    • University Hospital of Modena
  • MI
    • Milan, MI, Italy, 20154
      • Ospedale dei Bambini "Vittore Buzzi"
  • RE
    • Reggio Emilia, RE, Italy, 42123
      • Arcispedale Santa Maria Nuova Reggio Emilia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 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; 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.; Other Names: Probiotic
Active Comparator: Probiotic; 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; 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.; Other Names: Probiotic

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROM	Prelabor rupture of membranes evaluated according to clinical signs or fibronectin test	pre-labor
Pathologic APGAR score	The Apgar score is a measure of a baby's condition after birth. It guides midwives, doctors and nurses as to whether a baby needs immediate treatment or monitoring. It is used to check a newborn baby born at 1 minute and 5 minutes after their birth. It is named after Dr Virginia Apgar who developed the score. The Apgar score goes from 0 to 10 and it is classified as pathologic when is </= 7	at delivery
Need for neonatal antibiotics	Rate of neonates requiring antibiotics within the first 48h of life	within the first 48 hours after birth
Neonatal sepsis	Rate of neonates developing a sepsis	within the first week after birth

Collaborators and Investigators

• Sponsor: University of Modena and Reggio Emilia
• Collaborators: Daniela Menichini; Maria Longo

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Actual): September 30, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: October 5, 2021
• First Submitted That Met QC Criteria: December 13, 2021
• First Posted (Actual): December 14, 2021

Study Record Updates

• Last Update Posted (Actual): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Pregnancy; Probiotics; GBS colonization
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Infant, Newborn, Diseases; Sepsis; Neonatal Sepsis
• Other Study ID Numbers: AOU 0025949/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No