Probiotics and GBS Colonization in Pregnancy
Primary Purpose
GBS Rectovaginal Colonization, Neonatal Sepsis
Status
Suspended
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Respecta
Sponsored by
About this trial
This is an interventional prevention trial for GBS Rectovaginal Colonization focused on measuring Probiotics, Pregnancy, GBS colonization
Eligibility Criteria
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.
Sites / Locations
- Ospedale dei Bambini "Vittore Buzzi"
- Arcispedale Santa Maria Nuova Reggio Emilia
- University Hospital of Modena
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Probiotic
Arm 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.
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).
Outcomes
Primary Outcome Measures
GBS Rectovaginal colonization
Rate of colonized GBS pregnant (carriers) at the time of antepartum screening (35-37 ^ week).
Secondary Outcome Measures
Intrapartum antibiotics profilaxisi
Rata of women requiring antibiotic profilaxis intrapartum
Full Information
NCT ID
NCT05156333
First Posted
October 5, 2021
Last Updated
November 2, 2022
Sponsor
University of Modena and Reggio Emilia
Collaborators
Daniela Menichini, Maria Longo
1. Study Identification
Unique Protocol Identification Number
NCT05156333
Brief Title
Probiotics and GBS Colonization in Pregnancy
Official Title
Probiotics in Pregnancy and Rectovaginal Group B Streptococcus (GBS) Colonization
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Suspended
Why Stopped
Uneffective
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Modena and Reggio Emilia
Collaborators
Daniela Menichini, Maria Longo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GBS Rectovaginal Colonization, Neonatal Sepsis
Keywords
Probiotics, Pregnancy, GBS colonization
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigator
Masking Description
The randomization (1: 1) will take place in each center, using the same allocation sequence, in blocks of 4, with the indication of the treatment code inserted in a white, closed envelope. The code will correspond to the number written on the packages to be administered and the list of codes containing the definition of the treatments, will be kept in a sealed envelope, by a collaborator of the PI (Head Nurse), and opened upon completion of the study or at the time of need, in case maternal-fetal or neonatal serious adverse event.
No member of the research team knows which treatment the patients receive because both the active and the placebo are packaged identically and are contained in identical white boxes. Only the randomization numbers distinguish them.
Allocation
Randomized
Enrollment
402 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Probiotic
Arm Type
Active Comparator
Arm 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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Respecta
Other Intervention Name(s)
Probiotic
Intervention Description
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.
Primary Outcome Measure Information:
Title
GBS Rectovaginal colonization
Description
Rate of colonized GBS pregnant (carriers) at the time of antepartum screening (35-37 ^ week).
Time Frame
at 35-37 weeks
Secondary Outcome Measure Information:
Title
Intrapartum antibiotics profilaxisi
Description
Rata of women requiring antibiotic profilaxis intrapartum
Time Frame
during labor
Other Pre-specified Outcome Measures:
Title
PROM
Description
Prelabor rupture of membranes evaluated according to clinical signs or fibronectin test
Time Frame
pre-labor
Title
Pathologic APGAR score
Description
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
Time Frame
at delivery
Title
Need for neonatal antibiotics
Description
Rate of neonates requiring antibiotics within the first 48h of life
Time Frame
within the first 48 hours after birth
Title
Neonatal sepsis
Description
Rate of neonates developing a sepsis
Time Frame
within the first week after birth
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Ospedale dei Bambini "Vittore Buzzi"
City
Milan
State/Province
MI
ZIP/Postal Code
20154
Country
Italy
Facility Name
Arcispedale Santa Maria Nuova Reggio Emilia
City
Reggio Emilia
State/Province
RE
ZIP/Postal Code
42123
Country
Italy
Facility Name
University Hospital of Modena
City
Modena
ZIP/Postal Code
41124
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Probiotics and GBS Colonization in Pregnancy
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