Probiotics and GBS Colonization in Pregnancy

Neonatal Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05156333
• Other study ID #: AOU 0025949/19
• Status: Suspended
• Phase: N/A
• Start date: October 15, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2022
• Source: University of Modena and Reggio Emilia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 402
• Est. completion date: December 31, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neonatal Sepsis

Intervention

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.

Locations

Country	Name	City	State
Italy	Ospedale dei Bambini "Vittore Buzzi"	Milan	MI
Italy	University Hospital of Modena	Modena
Italy	Arcispedale Santa Maria Nuova Reggio Emilia	Reggio Emilia	RE

Sponsors (3)

Lead Sponsor	Collaborator
University of Modena and Reggio Emilia	Daniela Menichini, Maria Longo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PROM	Prelabor rupture of membranes evaluated according to clinical signs or fibronectin test	pre-labor
Other	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	at delivery
Other	Need for neonatal antibiotics	Rate of neonates requiring antibiotics within the first 48h of life	within the first 48 hours after birth
Other	Neonatal sepsis	Rate of neonates developing a sepsis	within the first week after birth
Primary	GBS Rectovaginal colonization	Rate of colonized GBS pregnant (carriers) at the time of antepartum screening (35-37 ^ week).	at 35-37 weeks
Secondary	Intrapartum antibiotics profilaxisi	Rata of women requiring antibiotic profilaxis intrapartum	during labor