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.
Study 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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
40 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
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).
Trial sites (1)
Facility
City
Region
Status
Umberto I Hospital, University of Rome "Sapienza"
Rome
Lazio
More University of Roma La Sapienza trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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