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

Not Applicable

Active, not recruiting

• Conditions: Endometriosis; Bacterial Vaginosis; Healthy Volunteer
• Interventions: Dietary Supplement: Multi-strain Oral Probiotic (CDS22-formula)

• Registration Number: NCT06592976
• Lead Sponsor: University of Roma La Sapienza

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-21
• Status Verified: 2024-09
• Study First Submitted: 2024-09-04
• Study First Submitted QC: 2024-09-09
• Last Update Submitted: 2024-09-09
• Study First Posted: 2024-09-12
• Last Update Posted: 2024-09-12
• Primary Completion: 2024-12-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 123

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Women with endometriosis	Multi-strain Oral Probiotic (CDS22-formula)	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Umberto I Hospital, University of Rome "Sapienza" 🇮🇹 Rome, Lazio, Italy