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Effects of a Multi-strain Oral Probiotic on the Vaginal Microbiota Composition in Healthy Women and Women with Endometriosis

StatusUnknown
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 19, 2024 (before its estimated December 31, 2024 completion). Its status may not reflect the trial's current state.

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Active, Not Recruiting
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Endometriosis is a chronic inflammatory disease affecting approximately 10-15% of reproductive age women, and, in recent years, an association between this pathology and dysbiosis, either involving the gut or the genital microbiota, has been hypothesized. Therefore, the aim of the study is to investigate the etiopathogenetic role of cervico-vaginal microbiota, and its relationship to the gut microbiota, in women with endometriosis. Furthermore, the effects of a multi-strain oral probiotic formulation will be evaluated on the composition of the genital microbiota in healthy women and patients with endometriosis.
Trial Details
NCT Number NCT06592976
Lead Sponsor University of Roma La Sapienza
Conditions
(from sponsor)		 Endometriosis, Bacterial Vaginosis, Healthy Volunteer
Related terms Endometriosis, Vaginosis, Bacterial
Enrollment 123 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov