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

University of Roma La Sapienza

Status

Active, not recruiting

Conditions

Endometriosis

Healthy Volunteer

Bacterial Vaginosis

Treatments

Dietary Supplement: Multi-strain Oral Probiotic (CDS22-formula)

Study type

Interventional

Funder types

Other

Identifiers

NCT06592976

0751/2020

Details and patient eligibility

About

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.

Enrollment

123 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

age between 20 and 40 years old;
clinical diagnosis of endometriosis via gynecological examination and transvaginal ultrasound (TVUS);
genital healthy condition as confirmed via gynecological examination.

Exclusion criteria

pre-menarche or menopause status;
diabetes, neoplastic diseases, urinary or genital infections in the past 6 months
bowel and/or liver disorders;
current treatment with oral contraceptive or progestins, prokinetics, antacids or proton pump in-hibitors;
sexual activity in the week before sampling;
recent or current antibiotic treatment (oral or topical);
the use of probiotics and/or prebiotics for three months before the enrolment.