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

NCT05433909 | Unknown

• 1 other identifier: 0009206 u
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Diagnosis; Microbiota; immunoassay

Outcome Measures

Primary Outcomes (2)

• Intestinal, vaginal and endometrial microbiota in patients with and without endometriosis

  The intestinal, vaginal and endometrial microbiota in patients with endometriosis is different than the intestinal, vaginal and endometrial microbiota in patients without endometriosis

  8 months

• inflammatory, immunophenotype and hormonal status in patients with and without endometriosis

  Differences of the inflammatory state, immunophenotype and hormonal status of the two groups of patients.

  8 months

Secondary Outcomes (3)

• Molecular, immunological characteristics of the inflammatory endometriosis environment

  8 months

• Microbiota and sites, symptoms, hormonal treatments of endometriosis

  8 months

• The impact of the various factors in determining the disease

  8 months

Study Arms (2)

Endometriosis group

EXPERIMENTAL

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

Diagnostic Test: Blood, fecal, vaginal and endometrial liquid samples

Control Group

EXPERIMENTAL

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.

Diagnostic Test: Blood, fecal, vaginal and endometrial liquid samples

Interventions

Blood, fecal, vaginal and endometrial liquid samples 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; Endometriosis group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Milan, 20122, Italy

RECRUITING

MeSH Terms

Conditions

Endometriosis; Disease

Interventions

Blood Specimen Collection; Defecation

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Laura Buggio, MD

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Buggio, MD

CONTACT

0255032318; laura.buggio@policlinico.mi.it

Dhouha Dridi, MD

CONTACT

0255032318; dhouha.dridi@policlinico.mi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Biological non-pharmacological Pilot study.

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: June 27, 2022
• Study Start: April 9, 2022
• Primary Completion: September 30, 2023
• Study Completion: November 30, 2023
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)