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Probiotics and GBS Colonization in Pregnancy

NCT05156333 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 402

Last updated 2022-11-07

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Daniela Menichini

    collaborator UNKNOWN

  • Maria Longo

    collaborator UNKNOWN

  • University of Modena and Reggio Emilia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-15
Primary Completion
2022-09-30
Completion
2022-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05156333 on ClinicalTrials.gov