Microbiota and Immunoassay in Women With and Without Endometriosis: a Pilot Study

Not Applicable

Recruiting

• Conditions: Endometriosis-related Pain; Endometriosis
• Interventions: Diagnostic Test: Blood, fecal, vaginal and endometrial liquid samples

• Registration Number: NCT05433909
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Brief Summary

Endometriosis is an estrogen-dependent chronic inflammatory disease characterized by the presence of endometrial tissue outside the uterine cavity. This pathology has a prevalence of about 5-10% in reproductive-aged women. Endometriosis therapy uses two options: surgical or medical (hormonal) but none can be considered completely resolving. Related signs and symptoms include dysmenorrhea, dyspareunia, infertility, dysuria and dyschezia. In addition to typical gynecological symptoms, gastrointestinal symptoms (bloating, nausea, constipation, diarrhea and vomiting) affect up to 90% of patients with endometriosis. Despite its high prevalence and associated morbidity, its etiology is still unclear and is thought to be multifactorial, and genetic, hormonal, environmental and immunological factors contribute to it. Several studies have shown a significant association between abnormal immune response and maintenance of disease activity in women with endometriosis.

The microbiome contains all the genetic material of microbes, including bacteria, fungi, viruses and Archaea, which live inside the host and regulate various physiological functions. The set of these bacteria, fungi, viruses and Archaea is called a microbiota. The influence of the microbiome on immunomodulation and the development of various inflammatory diseases is well established. Conversely, little is known about the presence and composition of the microbiome in the female reproductive system and its role in the development of endometriosis or other gynecological conditions. Considering the altered inflammatory state typical of endometriosis, it seems logical to postulate a potential role of the microbiome in the etiopathogenesis of this pathology. Interestingly, the microbiome affects estrogen metabolism and estrogen affects the gut microbiome. Since endometriosis is an estrogen-dependent disease, a picture of intestinal dysbiosis resulting in abnormal circulating estrogen levels could potentially contribute to the development of this disease.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-09
• Study Start: 2022-04-09
• Study First Submitted QC: 2022-06-22
• Study First Posted: 2022-06-27
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-22
• Last Update Posted: 2023-05-23
• Primary Completion: 2023-09-30
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• BMI <30 kg / m2
• no hormonal therapy (estrogen-progestin, progestogen, GnRH analogues) in progress for at least 1 month
• the endometriosis group include women who will undergo surgery for endometriosis. The control group include women who will undergo surgery for other gynecological indications (i.e .: abdominal surgical emergencies, tubal infertility, non-endometriotic ovarian cysts) in which the presence of endometriosis will be excluded during the surgery.

Exclusion Criteria

• hormonal therapy in progress (estrogen-progestins, progestins, GnRH analogues)
• antibiotic and / or probiotic therapy in the 8 weeks before the samples
• pregnancy
• menopausal state
• BMI ≥ 30 kg / m2
• presence of active systemic diseases, neoplasms, positive clinical history for autoimmune diseases, active vaginosis or positive history for pelvic inflammatory disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endometriosis group	Blood, fecal, vaginal and endometrial liquid samples	The endometriosis group will include women who will undergo surgery for endometriosis.
Control Group	Blood, fecal, vaginal and endometrial liquid samples	The control group include women who will undergo surgery for other gynecological diseases in which the presence of endometriosis will be excluded during the operation.

Primary Outcome Measures

Name	Time	Method
Intestinal, vaginal and endometrial microbiota in patients with and without endometriosis	8 months	The intestinal, vaginal and endometrial microbiota in patients with endometriosis is different than the intestinal, vaginal and endometrial microbiota in patients without endometriosis
inflammatory, immunophenotype and hormonal status in patients with and without endometriosis	8 months	Differences of the inflammatory state, immunophenotype and hormonal status of the two groups of patients.

Secondary Outcome Measures

Name	Time	Method
Molecular, immunological characteristics of the inflammatory endometriosis environment	8 months	the molecular and immunological characteristics of the inflammatory environment of endometriotic lesions and peripheral blood changed from women with and without endometriosis
Microbiota and sites, symptoms, hormonal treatments of endometriosis	8 months	Any differences regarding the composition of the microbiota based on the location of the disease, the presence of symptoms or previous hormonal treatments.
The impact of the various factors in determining the disease	8 months	The relative impact of the various factors in determining the disease combining characteristics of the microbiota with clinical data (genetic, serological, immunological and metabolic).

Trial Locations

Locations (1)

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico; 🇮🇹 Milan, Italy