EndometriosisNCT06266897
A Study on the Correlation Between Endometriosis and Intra-tissue Microbiota
An observational study of Endometriosis, run by Zhujiang Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 52 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 18 Jun 2023to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 52 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 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.
Who may be able to join
- Women aged 18-52 years old.
- Regular menstruation with a cycle of 28-35 days.
- No sexual intercourse 1 week before the operation.
- No systemic or local use of antibiotics and probiotics for 6 months prior to surgery.
- No history of acute or chronic pelvic inflammatory disease.
- Subjects fully understand the significance of the study and sign the informed consent form.
Who cannot join
- In pregnancy.
- Intraoperative conditions or pathological examination suggest a malignant or junctional disease.
- Severe anatomical abnormalities of the pelvis.
- Pelvic contamination with large amounts of blood during laparoscopic operation.
- History of gene therapy, blood transfusion, stem cell therapy, or bone marrow transplantation
- Psychiatric, personality disorders, or abuse of psychoactive substances.
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- Immunodeficiencies, allergies, or autoimmune diseases.
- Contraindications to endotracheal intubation anesthesia.
- Absolute or relative contraindications to laparoscopic or hysteroscopic surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital
Guangzhou, Guangdong, 510280
Ying Ma, +8613113361169, mayingwuzhuoyi@126.com
About this study
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.
Read the detailed 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.
- Conditions
- Endometriosis
- Keywords
- Microbiota, Microbiome, Endometriosis
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| EM group | Patient diagnosed with endometriosis after confirmation by laparoscopic surgery and pathologic examination. | |
| Control group | Patient diagnosed without endometriosis after confirmation by laparoscopic surgery and pathologic examination, usually with benign gynecologic conditions such as uterine fibroids or teratomas. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start18 Jun 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying Ma, PhD, Principal investigator, Zhujiang Hospital, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266897
- Sponsor's protocol ID
- ZhujiangEM
- Status last verified
- Jan 2024
- First submitted
- 25 Jan 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Correlation Between Endometriosis and Intra-tissue Microbiota
- ClinicalTrials.gov ID
- NCT06266897
- Acronym / sponsor ID
- ZhujiangEM
- Conditions
- Endometriosis
- Keywords
- Microbiota, Microbiome, Endometriosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 18 Jun 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EM group | – | –Patient diagnosed with endometriosis after confirmation by laparoscopic surgery and pathologic examination. |
| Control group | – | –Patient diagnosed without endometriosis after confirmation by laparoscopic surgery and pathologic examination, usually with benign gynecologic conditions such as uterine fibroids or teratomas. |
Who may qualify
- Ages
- 18 to 52 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- Women aged 18-52 years old.
- Regular menstruation with a cycle of 28-35 days.
- No sexual intercourse 1 week before the operation.
- No systemic or local use of antibiotics and probiotics for 6 months prior to surgery.
- No history of acute or chronic pelvic inflammatory disease.
Key exclusion criteria (9 listed)
- In pregnancy.
- Intraoperative conditions or pathological examination suggest a malignant or junctional disease.
- Severe anatomical abnormalities of the pelvis.
- Pelvic contamination with large amounts of blood during laparoscopic operation.
- History of gene therapy, blood transfusion, stem cell therapy, or bone marrow transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Metagenomics Next Generation Sequencing of the Intra-tissue Microbiota Composition
Time frame: 3 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ying Ma, PhD principal investigator
Zhujiang Hospital, Southern Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ziwei Zhou, Dr (+8615626400134, vivienchow@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metagenomics Next Generation Sequencing of the Intra-tissue Microbiota Composition (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.