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

NCT ID: NCT05433909

Last Updated: 2023-05-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-09
• Study Completion Date: 2023-11-30

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.

Conditions

Endometriosis; Endometriosis-related Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Endometriosis group

The endometriosis group will include women who will undergo surgery for endometriosis.

Group Type: EXPERIMENTAL

Blood, fecal, vaginal and endometrial liquid samples

Intervention Type: DIAGNOSTIC_TEST

During the surgical pre-hospitalization, eligible patients who accept participation in the study will undergo a blood sample and collection of stool samples.

Before surgery, after anesthesia, they will undergo a vaginal swab and endometrial fluid sampling.

Control Group

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.

Group Type: EXPERIMENTAL

Blood, fecal, vaginal and endometrial liquid samples

Intervention Type: DIAGNOSTIC_TEST

During the surgical pre-hospitalization, eligible patients who accept participation in the study will undergo a blood sample and collection of stool samples.

Before surgery, after anesthesia, they will undergo a vaginal swab and endometrial fluid sampling.

Interventions

Blood, fecal, vaginal and endometrial liquid samples

During the surgical pre-hospitalization, eligible patients who accept participation in the study will undergo a blood sample and collection of stool samples.

Before surgery, after anesthesia, they will undergo a vaginal swab and endometrial fluid sampling.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role: lead

Responsible Party

Direzione Ginecologia

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laura Buggio, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Locations

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Laura Buggio, MD

Role: CONTACT

laura.buggio@policlinico.mi.it

0255032318

Dhouha Dridi, MD

Role: CONTACT

dhouha.dridi@policlinico.mi.it

0255032318

Facility Contacts

Laura buggio, MD

Role: primary

laura.buggio@policlinico.mi.it

+393388720855

Dhouha Dridi, MD

Role: backup

dhouha.dridi@policlinico.mi.it

+393429370961

Other Identifiers

0009206 u

Identifier Type: -

Identifier Source: org_study_id