Microbiota and Immunoassay in Women With and Without Endometriosis: a Pilot Study
Primary Purpose
Endometriosis, Endometriosis-related Pain
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Blood, fecal, vaginal and endometrial liquid samples
Sponsored by
About this trial
This is an interventional diagnostic trial for Endometriosis focused on measuring Diagnosis, Microbiota, immunoassay
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Endometriosis group
Control Group
Arm Description
The endometriosis group will include women who will undergo surgery for endometriosis.
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.
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
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
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.
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).
Full Information
NCT ID
NCT05433909
First Posted
March 9, 2022
Last Updated
May 22, 2023
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
1. Study Identification
Unique Protocol Identification Number
NCT05433909
Brief Title
Microbiota and Immunoassay in Women With and Without Endometriosis: a Pilot Study
Official Title
Microbiota and Immunoassay in Women With and Without Endometriosis: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 9, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Endometriosis-related Pain
Keywords
Diagnosis, Microbiota, immunoassay
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Biological non-pharmacological Pilot study.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Endometriosis group
Arm Type
Experimental
Arm Description
The endometriosis group will include women who will undergo surgery for endometriosis.
Arm Title
Control Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood, fecal, vaginal and endometrial liquid samples
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intestinal, vaginal and endometrial microbiota in patients with and without endometriosis
Description
The intestinal, vaginal and endometrial microbiota in patients with endometriosis is different than the intestinal, vaginal and endometrial microbiota in patients without endometriosis
Time Frame
8 months
Title
inflammatory, immunophenotype and hormonal status in patients with and without endometriosis
Description
Differences of the inflammatory state, immunophenotype and hormonal status of the two groups of patients.
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Molecular, immunological characteristics of the inflammatory endometriosis environment
Description
the molecular and immunological characteristics of the inflammatory environment of endometriotic lesions and peripheral blood changed from women with and without endometriosis
Time Frame
8 months
Title
Microbiota and sites, symptoms, hormonal treatments of endometriosis
Description
Any differences regarding the composition of the microbiota based on the location of the disease, the presence of symptoms or previous hormonal treatments.
Time Frame
8 months
Title
The impact of the various factors in determining the disease
Description
The relative impact of the various factors in determining the disease combining characteristics of the microbiota with clinical data (genetic, serological, immunological and metabolic).
Time Frame
8 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Buggio, MD
Phone
0255032318
Email
laura.buggio@policlinico.mi.it
First Name & Middle Initial & Last Name or Official Title & Degree
Dhouha Dridi, MD
Phone
0255032318
Email
dhouha.dridi@policlinico.mi.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Buggio, MD
Organizational Affiliation
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
City
Milan
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura buggio, MD
Phone
+393388720855
Email
laura.buggio@policlinico.mi.it
First Name & Middle Initial & Last Name & Degree
Dhouha Dridi, MD
Phone
+393429370961
Email
dhouha.dridi@policlinico.mi.it
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Microbiota and Immunoassay in Women With and Without Endometriosis: a Pilot Study
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