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

NCT ID: NCT06592976

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-21
• Study Completion Date: 2025-05-31

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.

Conditions

Endometriosis; Bacterial Vaginosis; Healthy Volunteer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Women with endometriosis

Group Type: EXPERIMENTAL

Multi-strain Oral Probiotic (CDS22-formula)

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Marisa Di Pietro

Professor in Microbiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Umberto I Hospital, University of Rome "Sapienza"

Rome, Lazio, Italy

Countries

Italy

Other Identifiers

0751/2020

Identifier Type: -

Identifier Source: org_study_id