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Active, Not Recruiting

NCT Number: NCT06592976

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Endometriosis Bacterial Infections Bacterial Infections and Mycoses Bacterial Vaginosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Healthy Volunteer Infections Urogenital Diseases Vaginal Diseases Vaginitis Vaginosis, Bacterial

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Umberto I Hospital, University of Rome "Sapienza"

Rome, Lazio, 00185, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

    Time frame: 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 outcomes

  1. 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.

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

Effects of Gut Microflora on Cervico-vaginal Microenvironment in Women with Endometriosis (Original Version: Effetti Della Flora Intestinale Sul Microambiente Cervico-vaginale in Donne Con Endometriosi)

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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