Microbiome and Immunologic Analysis - Women With Endometriosis

NCT ID: NCT04159740

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 48 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-06
• Study Completion Date: 2022-03-11

Brief Summary

The primary goal of this study is to assess differences in the microbiome between women with and without endometriosis.

A second goal of this study is to assess immunologic differences between the eutopic (within the uterus) and ectopic (outside of the uterus) endometrial tissue in women with endometriosis.

In order to investigate these areas of interest, 25 women with endometriosis and 25 women without endometriosis will be enrolled. All women will be undergoing a previously scheduled surgical procedure at which time presence or absence of endometriosis will be confirmed and specimens will be obtained.

Detailed Description

Endometriosis is a chronic gynecologic condition where implants of endometrial glands and stroma are present outside of the uterus. It occurs in 6-10% of women of reproductive age and is characterized by dysmenorrhea, chronic pelvic pain, dyspareunia, or infertility. In addition to symptom burden, there are significant direct costs related to diagnosis and treatment of disease, as well as indirect costs related to absenteeism from school and work, loss of productivity, and unemployment. The estimated national economic burden in the United States related to these costs is approximately 78 billion dollars per year. While clinical signs and symptoms may be suggestive of endometriosis, the gold standard for diagnosis requires surgical confirmation of disease.

The pathogenesis of endometriosis is complex and likely multifactorial with genetic, epigenetic, environmental, and immunologic factors. An increasing number of studies have also suggested the role of the microbiome in human health and development of disease. This study aims to investigate possible differences in the microbiome and immunologic factors that could contribute to pathogenesis of this disease. Findings from this study could potentially contribute to the development of of a less invasive, non-surgical diagnostic test for endometriosis.

Conditions

Endometriosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Endometriosis - Cases

Premenopausal women with suspected endometriosis, planning to undergo laparoscopic surgery.

Tissue and blood collection

Intervention Type: OTHER

Tissue and swab (cells) collection for microbiome analysis. Blood collection for immune markers.

Controls

Premenopausal women without endometriosis, planning to undergo laparoscopic surgery for non-cancer indications including elective salpingectomy, tubal ligation or surgical procedures for abnormal uterine bleeding

Tissue and blood collection

Intervention Type: OTHER

Tissue and swab (cells) collection for microbiome analysis. Blood collection for immune markers.

Interventions

Tissue and blood collection

Tissue and swab (cells) collection for microbiome analysis. Blood collection for immune markers.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Females, age 18 years or older
• Undergoing laparoscopy (conventional or robotic) with or without hysterectomy for non-cancer indications and including women from two groups:
• Suspected endometriosis
• Elective salpingectomy or tubal ligation or abnormal uterine bleeding
• Understands study procedures
• Willing and able to provide signed informed consent

Exclusion Criteria

• Postmenopausal
• Currently pregnant or lactating
• Prior hysterectomy or oophorectomy
• Undergoing hysterectomy via vaginal or abdominal approach
• Undergoing hysterectomy or laparoscopy for suspected malignancy
• Use of antibiotics within 2 weeks prior to surgery
• Use of hormone therapy for endometriosis or contraception within 4 weeks prior to surgery
• Diagnosis or treatment of vaginitis during the past 6 months prior to surgery
• Personal history of autoimmune or inflammatory disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Marina R. Walther-Antonio

Assistant Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marina R Walther-Antonio, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Adela G Cope, M.D.

Role: STUDY_CHAIR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

18-011885

Identifier Type: -

Identifier Source: org_study_id