NCT06592976

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

Effects of Gut Microflora on Cervico-vaginal Microenvironment in Women with Endometriosis (Original Version: Effetti Della Flora Intestinale Sul Microambiente Cervico-vaginale in Donne Con Endometriosi)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Endometriosis
• Bacterial Vaginosis
• Healthy Volunteer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Multi-strain Oral Probiotic (CDS22-formula)	All patients received the probiotic product CDS22-formula (also known under the tradenames Visbiome, De Simo-ne, Vivomixx) as acid-resistant oral capsules (twice daily for 2 months), containing 1.12 x 10\^11 live bacteria per capsule.

Timeline

• Start date: 2020-10-21
• Primary completion: 2024-12-31
• Completion: 2025-05-31
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: Italy