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ACTIVE NOT RECRUITING
NCT06592976
NA

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

Sponsor: University of Roma La Sapienza

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

FEMALE

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

123

Start Date

2020-10-21

Completion Date

2025-05-31

Last Updated

2024-09-19

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

Umberto I Hospital, University of Rome "Sapienza"

Rome, Lazio, Italy