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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women with endometriosis | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-strain Oral Probiotic (CDS22-formula) | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At the time of enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Umberto I Hospital, University of Rome "Sapienza" | Rome | Lazio | 00185 | Italy |
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|
| At the time of enrollment and after 2 months of probiotic supplementation |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D016585 | Vaginosis, Bacterial |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
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