Bacterial Vaginosis, Endometriosis, Healthy Volunteer
Conditions
Keywords
Gut microbiota, Vaginal microbiota, Probiotic, endometriosis, bacterial vaginosis, 16s metagenomic
Brief 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.
Interventions
DIETARY_SUPPLEMENTMulti-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.
Sponsors
University of Roma La Sapienza
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | At the time of enrollment | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | At the time of enrollment and after 2 months of probiotic supplementation | 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). |
Countries
Italy
Outcome results
None listed