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

N/AActive Not RecruitingNCT06592976

University of Roma La Sapienza123 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

123

Conditions

Endometriosis Bacterial Vaginosis Healthy Volunteer

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Comparison in the mean microbial diversity of the vaginal and gut microbiota between women with endometriosis and healthy volunteers, as assessed by Shannon Diversity Index (alpha-measure) and UniFrac analysis (beta measure), calculated in qiime2.

Microbial diversity through Shannon diversity index and UniFrac analysis will be calculated from the number and type of bacterial species in the vaginal and gut microbiota as assessed by the sequencing of the hypervariable region (v3-v4) of the bacterial 16s rDNA via metagenomic analysis (Illumina MiSeq platform).

Time frame: At the time of enrollment

Secondary Outcomes

Changes in the mean microbial diversity (Shannon Diversity Index and UniFrac analysis) of the vaginal microbiota at two month supplementation, from baseline, of the probiotic product in either healthy women or women with endometriosis.

Microbial diversity through Shannon diversity index (alpha measure) and UniFrac analysis (beta measure) will be calculated in qiime2 from the number and type of bacterial species in the vaginal and gut microbiota as assessed by the sequencing of the hypervariable region (v3-v4) of the bacterial 16s rDNA via metagenomic analysis (Illumina MiSeq platform).

Time frame: At the time of enrollment and after 2 months of probiotic supplementation