An interventional study of Multi-strain Oral Probiotic (CDS22-formula) in Endometriosis, Bacterial Vaginosis and Healthy Volunteer, sponsored by University of Roma La Sapienza. Active, not recruiting at 1 site in Italy. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University of Roma La Sapienza · Not applicable, Interventional, and Basic science
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.
220 studies on the registry are indexed under Vaginosis, Bacterial; 36 are open to participants now.
This study's enrollment of 123 is above the median of 100 across 187 interventional studies indexed under Vaginosis, Bacterial.
Browse Vaginosis, Bacterial studies →University of Roma La Sapienza is the lead sponsor of 388 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
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.
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
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
Plan to share: No
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This study is active, not recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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University of Roma La Sapienza