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Microbiome and Immunologic Analysis - Women With Endometriosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04159740
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Marina R. Walther-Antonio, Mayo Clinic

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.


Condition or disease Intervention/treatment
Endometriosis Other: Tissue and blood collection

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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Microbiome and Immunologic Analysis of the Lower and Upper Female Reproductive Tract in Women With Endometriosis
Actual Study Start Date : February 6, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Group/Cohort Intervention/treatment
Endometriosis - Cases
Premenopausal women with suspected endometriosis, planning to undergo laparoscopic surgery.
Other: Tissue and blood collection
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
Other: Tissue and blood collection
Tissue and swab (cells) collection for microbiome analysis. Blood collection for immune markers.




Primary Outcome Measures :
  1. Microbiome composition in genital tract and gastrointestinal tract [ Time Frame: At time of surgery ]

Secondary Outcome Measures :
  1. Immunostaining of eutopic and ectopic endometrium for immune factors, immune cells, and fibrosis [ Time Frame: At time of surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Premenopausal women with or without endometriosis, planning to undergo laparoscopic surgery for non-cancer indications.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159740


Contacts
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Contact: Emily N Smith, RN 507-266-4813 smith.emily3@mayo.edu
Contact: Maureen A Lemens, BSN 507-293-1487 lemens.maureen@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Emily N Smith, RN    507-266-4813    smith.emily3@mayo.edu   
Contact: Maureen A Lemens, BSN    507-293-1487    lemens.maureen@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Marina R Walther-Antonio, Ph.D. Mayo Clinic
Study Chair: Adela G Cope, M.D. Mayo Clinic
Additional Information:
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Responsible Party: Marina R. Walther-Antonio, Assistant Professor of Surgery, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04159740    
Other Study ID Numbers: 18-011885
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female