A Study on the Correlation Between Endometriosis and Intra-tissue Microbiota

Endometriosis Clinical Trial

Official title:

A Study on the Correlation Between Endometriosis and Intra-tissue Microbiota

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06266897
• Other study ID #: ZhujiangEM
• Status: Recruiting
• Start date: June 18, 2023
• Est. completion date: December 2026

Study information

• Verified date: January 2024
• Source: Zhujiang Hospital
• Contact: Ziwei Zhou, Dr
• Phone: +8615626400134
• Email: vivienchow[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Endometriosis (EM) is a common gynecological condition, but the pathogenesis of it has not yet been clarified. Here, the investigators wanted to investigate the correlation between endometriosis and the intra-tissue microbiota. The investigators planed to collect serum, vaginal swabs, cervical mucus, feces, peritoneal fluid, and endometrial tissue for sequencing and experiments.

Description:

Endometriosis (EM) is a common gynecological condition that occurs in women of reproductive age and is characterized by pain, masses, and infertility. EM is a tumor-like disease that is invasive, metastatic, recurrent, but the pathogenesis of EM has not yet been clarified. Advances in the study of intratumoral microbiota provided increasing evidence confirming the presence and mechanism of bacteria in tumor tissues. Therefore, the investigators wanted to investigate the correlation between endometriosis and its microbiota in the endometrial tissue.

Participants in this study will be recruited in the obstetrics and Obstetrics and Gynecology Medical Center of Zhujiang Hospital. With reference to the inclusion and exclusion criteria, patients admitted for surgery were under screening. Participants were assigned to Endometriosis group after confirmation by laparoscopy together with biopsy analysis, while the control group was identified as non-EM patients, usually with benign gynecologic conditions such as uterine fibroids or teratomas.

The investigators will obtain serum, vaginal swabs, cervical mucus, and feces from the participant before surgery. The peritoneal fluid, eutopic endometrium, and ectopic endometrium lesion will also be collected if the surgical approach allows. The specimens will be sent for microbiota sequencing, transcriptome sequencing, metabolome sequencing, single cell sequencing, and laboratory experiments.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 52 Years

Eligibility

Inclusion Criteria:

1. Women aged 18-52 years old.

2. Regular menstruation with a cycle of 28-35 days.

3. No sexual intercourse 1 week before the operation.

4. No systemic or local use of antibiotics and probiotics for 6 months prior to surgery.

5. No history of acute or chronic pelvic inflammatory disease.

6. Subjects fully understand the significance of the study and sign the informed consent form.

Exclusion Criteria:

1. In pregnancy.

2. Intraoperative conditions or pathological examination suggest a malignant or junctional disease.

3. Severe anatomical abnormalities of the pelvis.

4. Pelvic contamination with large amounts of blood during laparoscopic operation.

5. History of gene therapy, blood transfusion, stem cell therapy, or bone marrow transplantation

6. Psychiatric, personality disorders, or abuse of psychoactive substances.

7. Immunodeficiencies, allergies, or autoimmune diseases.

8. Contraindications to endotracheal intubation anesthesia.

9. Absolute or relative contraindications to laparoscopic or hysteroscopic surgery.

Related Conditions & MeSH terms

• Endometriosis

Locations

Country	Name	City	State
China	Zhujiang Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metagenomics Next Generation Sequencing of the Intra-tissue Microbiota Composition	Using metagenomics sequencing of microbiota, compare the microbial composition differences of specimens derived from EM group and control group, including the alpha diversity(Shannon index, Simpson index, etc.), beta diversity(PCoA analysis, Bray-Curtis, etc.) differential taxonomy, and KEGG pathway prediction.	3 years