Probiotics and GBS Colonization in Pregnancy

NCT05156333 | Suspended

• 1 other identifier: AOU 0025949/19
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 3

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.

Conditions

GBS Rectovaginal Colonization; Neonatal Sepsis

Keywords

Probiotics; Pregnancy; GBS colonization

Outcome Measures

Primary Outcomes (1)

• GBS Rectovaginal colonization

  Rate of colonized GBS pregnant (carriers) at the time of antepartum screening (35-37 \^ week).

  at 35-37 weeks

Secondary Outcomes (1)

• Intrapartum antibiotics profilaxisi

  during labor

Other Outcomes (4)

• PROM

  pre-labor

• Pathologic APGAR score

  at delivery

• Need for neonatal antibiotics

  within the first 48 hours after birth

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Probiotic

ACTIVE COMPARATOR

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

Interventions

Respecta DIETARY_SUPPLEMENT

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.

Also known as: Probiotic

Placebo; Probiotic

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• low obstetric risk pregnant women by the 33rd week of gestation,
• vaginal delivery expected.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Modena and Reggio Emilia: lead
• Daniela Menichini: collaborator
• Maria Longo: collaborator

Study Sites (3)

Ospedale dei Bambini "Vittore Buzzi"

Milan, MI, 20154, Italy

Location

Arcispedale Santa Maria Nuova Reggio Emilia

Reggio Emilia, RE, 42123, Italy

Location

University Hospital of Modena

Modena, 41124, Italy

Location

MeSH Terms

Conditions

Neonatal Sepsis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Obstetrics and Gynecolocy department

Model Details: 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.

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: December 14, 2021
• Study Start: October 15, 2020
• Primary Completion: September 30, 2022
• Study Completion: December 31, 2022
• Last Updated: November 7, 2022

Record last verified: 2022-11

Locations

IT (3)