EndometriosisNCT05433909
Microbiota and Immunoassay in Women With and Without Endometriosis: a Pilot Study
A study testing Blood, fecal, vaginal and endometrial liquid samples in people with Endometriosis and Endometriosis-related Pain, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis, Endometriosis-related Pain
- What is being tested?
- Blood, fecal, vaginal and endometrial liquid samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 9 Apr 2022to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan, 20122
Laura buggio, MD, +393388720855, laura.buggio@policlinico.mi.it
Dhouha Dridi, MD, +393429370961, dhouha.dridi@policlinico.mi.it
About this study
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
- Being tested
- Blood, fecal, vaginal and endometrial liquid samples
- Keywords
- Diagnosis, Microbiota, immunoassay
- Medical subject headings
- Endometriosis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood, fecal, vaginal and endometrial liquid samplesDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Endometriosis group | Experimental | The endometriosis group will include women who will undergo surgery for endometriosis. Receives: 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. Receives: Diagnostic Test: Blood, fecal, vaginal and endometrial liquid samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 8 months
Secondary outcomes (3)
Molecular, immunological characteristics of the inflammatory endometriosis environment
the molecular and immunological characteristics of the inflammatory environment of endometriotic lesions and peripheral blood changed from women with and without endometriosis
Measured: 8 months
Microbiota and sites, symptoms, hormonal treatments of endometriosis
Any differences regarding the composition of the microbiota based on the location of the disease, the presence of symptoms or previous hormonal treatments.
Measured: 8 months
The impact of the various factors in determining the disease
The relative impact of the various factors in determining the disease combining characteristics of the microbiota with clinical data (genetic, serological, immunological and metabolic).
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start9 Apr 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Nov 2023 (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.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Biological non-pharmacological Pilot study.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Direzione Ginecologia, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Investigators
- Laura Buggio, MD, Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433909
- Sponsor's protocol ID
- 0009206 u
- Status last verified
- May 2023
- First submitted
- 9 Mar 2022
- Last updated
- 23 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiota and Immunoassay in Women With and Without Endometriosis: a Pilot Study
- ClinicalTrials.gov ID
- NCT05433909
- Acronym / sponsor ID
- 0009206 u
- Conditions
- Endometriosis, Endometriosis-related Pain
- Keywords
- Diagnosis, Microbiota, immunoassay
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 9 Apr 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 27 Jun 2022 (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 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Biological non-pharmacological Pilot study.
| Arm | Type | Receives |
|---|---|---|
| Endometriosis group | Experimental | Diagnostic Test: Blood, fecal, vaginal and endometrial liquid samplesThe endometriosis group will include women who will undergo surgery for endometriosis. |
| Control Group | Experimental | Diagnostic Test: Blood, fecal, vaginal and endometrial liquid samplesThe control group include women who will undergo surgery for other gynecological diseases in which the presence of endometriosis will be excluded during the operation. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood, fecal, vaginal and endometrial liquid samplesDuring 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. | Diagnostic test | Control Group, Endometriosis group |
Primary outcome
Intestinal, vaginal and endometrial microbiota in patients with and without endometriosis
Time frame: 8 months
The intestinal, vaginal and endometrial microbiota in patients with endometriosis is different than the intestinal, vaginal and endometrial microbiota in patients without endometriosis
inflammatory, immunophenotype and hormonal status in patients with and without endometriosis
Time frame: 8 months
Differences of the inflammatory state, immunophenotype and hormonal status of the two groups of patients.
3 secondary outcomes
Molecular, immunological characteristics of the inflammatory endometriosis environment
Time frame: 8 months
Microbiota and sites, symptoms, hormonal treatments of endometriosis
Time frame: 8 months
The impact of the various factors in determining the disease
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Individual participant dataSharing planned: No
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Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
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Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
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Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
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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. This study is not recruiting at the moment.
Laura Buggio, MD principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood, fecal, vaginal and endometrial liquid samples in people with Endometriosis and Endometriosis-related Pain, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 23 May 2023. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Buggio, MD (0255032318, laura.buggio@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal, vaginal and endometrial microbiota in patients with and without endometriosis (time frame: 8 months). The study lists 2 primary outcomes in all. 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 23 May 2023.