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NCT05156333

Probiotics and GBS Colonization in Pregnancy

Suspended NA Last updated 7 November 2022
What this trial tests

NA trial testing Respecta in GBS Rectovaginal Colonization in 402 participants. Suspended.

Timeline
15 October 2020
Primary endpoint
30 September 2022
31 December 2022

Quick facts

Lead sponsorUniversity of Modena and Reggio Emilia
PhaseNA
StatusSuspended
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeprevention
Enrollment402
Start date15 October 2020
Primary completion30 September 2022
Estimated completion31 December 2022
Sites3 locations across Italy

Drugs / interventions tested

Conditions studied

Sponsor

University of Modena and Reggio Emilia

Who can join

Adults 18 to 45, female only, with GBS Rectovaginal Colonization or Neonatal Sepsis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other University of Modena and Reggio Emilia trials

Trials by the same sponsor.

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Data sources for this page

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