Establishment of the Human Intestinal and Salivary Microbiota Biobank - Gynecological Diseases
NCT ID: NCT04698109
Last Updated: 2022-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
103 participants
OBSERVATIONAL
2021-02-11
2022-04-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The study will allow to:
* Provide biological samples (faeces, saliva, vaginal, urine) from healthy volunteers and patients suffering from selected disease to the first Italian microbiota biobank;
* Study microorganisms using different in vitro and in vivo techniques;
* Study the link between the microbiota and the disease. This study is part of the BIOMIS project (Project Code: ARS01\_01220), presented as part of the "Avviso per la presentazione di progetti di ricerca industriale e sviluppo sperimentale nelle 12 aree di specializzazione individuate dal PNR 2015-2020" and admitted to funding under the National Operational Program "Ricerca e Innovazione" 2014-2020 by directorial decree of MIUR - Department for Higher Education and Research - n. 2298 of 12 September 2018. BIOMIS includes several clinical studies that enrol patients with different pathologies to collect and store biological samples and study microbiota.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Development of a Microbiome Non-invasive Diagnosis Tool
NCT03330444
New Strategies to Evaluate the Reproductive Tract Microbiome
NCT06920797
Microbiota and Immunoassay in Women With and Without Endometriosis: a Pilot Study
NCT05433909
Omics Sequencing of Specimen Derived From Patients With Endometriosis
NCT05086484
Effects of a Multi-strain Oral Probiotic on the Vaginal Microbiota Composition in Healthy Women and Women with Endometriosis
NCT06592976
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The secondary aim is the characterization of microorganisms of the biobank and study of the microbiota-pathology relationship using meta-omics, in vitro and in vivo approaches, The study plans to enrol 100 subjects at Policlinic of Bari, according to the inclusion/exclusion criteria. The study participation is voluntary, and the subjects have the right to withdraw from the study at any time and for any reason.
During the study, 3 visits are planned:
* Visit 0 (V0), including description of the objectives and procedures study, signature written informed consent, inclusion/exclusion criteria evaluation, medical examination (blood pressure measurement, abdominal and thoracic physical examination), filling in of the anamnestic questionnaire, delivery of kits for the collection of fecal, salivary and urinary material to be reported at Visit 1 and delivery of a 3-day food diary, to be completed autonomously in the days preceding the Visit 1.
* Visit 1 (V1) - at least 4 days after V0, including delivery of the of the collected biological material (feces, saliva, urine), and of a 3-day food diary, filling in of the new signs and symptoms anamnestic questionnaire and collection of the vaginal swab by medical staff.
* Telephone evaluation: administration of a "Food Frequency Questionnaire" to assess the subjects' alimentary habits.
Standard Operative Procedures (SOP) for samples storing, transport and processing will be adopted to ensure samples stability and grant results validity and quality.
Following collections, samples will be processed in different aliquots that will be used for:
* routine screening;
* storage in the first Italian human microbiote biobank (I.R.C.C.S. - Istituto Tumori "Giovanni Paolo II", Bari);
* evaluation of the proteomic, metascriptomic, metabolomic, metagenomic, and metagenetic profile.
Furthermore, molecular characterization of pathogenic microorganisms and pathogenic biotypes (pathovars) of commensal species of subjects with selected pathologies will be conducted.
Part of the biological material will be used for animal studies on the physiopathological role of the human intestinal microbiota transplanted into mouse models of pathology and Germ-free mouse models (specific animal study protocol developed).
The study foresees no more than minimal risk associated with blood sampling procedures. All the necessary measures to avoid any risks / inconveniences resulting from participation of the subject under study will be taken.
The study is compliant with Good Clinical Practice. Study protocol and all related documents have been approved by approved by the Independent Ethics Committees (IEC) of the involved clinical sites.
To ensure the protection and confidentiality of the participants' data, all study activities will be carried out in accordance with the European General Data Protection Regulation, Regulation (EU) 2016/679, which repeals Directive 95/46/EC.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
recurrent cervicovaginitis
patients with recurrent cervicovaginitis
Biological sample collection
Collection of faeces, urine, saliva, vaginal swab for biobanking, to evaluate the proteomic, metascriptomic, metabolomic, metagenomic, and metagenetic profile, and to perform routine screening
Questionnaire
Anamnestic questionnaire, 3-day food questionnaire, Food Frequency Questionnaire
Medical examination
Blood pressure measurement, abdominal and thoracic physical examination
endometriosis
patients with endometriosis
Biological sample collection
Collection of faeces, urine, saliva, vaginal swab for biobanking, to evaluate the proteomic, metascriptomic, metabolomic, metagenomic, and metagenetic profile, and to perform routine screening
Questionnaire
Anamnestic questionnaire, 3-day food questionnaire, Food Frequency Questionnaire
Medical examination
Blood pressure measurement, abdominal and thoracic physical examination
repeated implantation failures
patients with repeated implantation failures
Biological sample collection
Collection of faeces, urine, saliva, vaginal swab for biobanking, to evaluate the proteomic, metascriptomic, metabolomic, metagenomic, and metagenetic profile, and to perform routine screening
Questionnaire
Anamnestic questionnaire, 3-day food questionnaire, Food Frequency Questionnaire
Medical examination
Blood pressure measurement, abdominal and thoracic physical examination
healthy volunteers
healthy volunteers
Biological sample collection
Collection of faeces, urine, saliva, vaginal swab for biobanking, to evaluate the proteomic, metascriptomic, metabolomic, metagenomic, and metagenetic profile, and to perform routine screening
Questionnaire
Anamnestic questionnaire, 3-day food questionnaire, Food Frequency Questionnaire
Medical examination
Blood pressure measurement, abdominal and thoracic physical examination
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Biological sample collection
Collection of faeces, urine, saliva, vaginal swab for biobanking, to evaluate the proteomic, metascriptomic, metabolomic, metagenomic, and metagenetic profile, and to perform routine screening
Questionnaire
Anamnestic questionnaire, 3-day food questionnaire, Food Frequency Questionnaire
Medical examination
Blood pressure measurement, abdominal and thoracic physical examination
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* healthy subjects aged between 18 and 45 years, in reproductive age
* BMI between 18.5-30
* omnivorous diet
* signature of the informed consent
PATIENTS WITH RECIDIVING CERVIC VAGINITIS
* healthy subjects aged between 18 and 45 years, in reproductive age
* Patients suffering from at least 3 episodes of relapsing cervicovaginitis per year: diagnosis of anaerobic vaginitis (AV) or bacterial vaginosis (BV) or vulvo-vaginal candidiasis (VVC) based on clinical symptoms and positive microscopic examination and / or positive vaginal culture
* BMI between 18.5-30
* omnivorous diet
* signature of the informed consent
PATIENTS WITH ENDOMETRIOSIS
* aged between 18 and 45 years, in reproductive age
* patients with endometriosis: diagnosis of endometriosis carried out with transvaginal ultrasound with associated elevation of CA125
* BMI between 18.5-30
* omnivorous diet
* signature of the informed consent
PATIENTS WITH REPEATED IMPLANT FAILURES (RIF)
* age between 18 and 45 years in reproductive age
* patients with RIF: patients who have followed PMA protocols with at least 3 failed attempts after transfer of good quality embryos
* BMI between 18.5-30
* omnivorous diet
* signature of the informed consent
Exclusion Criteria
* Current or previous infectious diseases (HAV, HBV, HCV, HIV, Cytomegalovirus, Epstein-Barr virus)
* HPV positive
* Chronic liver disease
* History of Clostridium difficile infections
* Recent (\<3 months) therapy with antibiotics, immunosuppressive drugs, chemotherapy
* Chronic therapy with proton pump inhibitors
* Recent (\<3 months) use of probiotics, laxatives or other aids (drugs / supplements) for the regulation of gastrointestinal activity
* Previous history of organ / tissue transplantation
* Recent onset of diarrhea
* Chronic diarrhea
* Chronic constipation
* Previous gastrointestinal surgery (eg gastric bypass)
* Recurring urinary tract infections (3 cases per year)
* Previous major acute cardiovascular diseases (myocardial infarction, stroke)
* Type 2 diabetes mellitus
* Hypertension
* eGFR (estimated glomerular filtration rate) lower than 60ml / minute and / or diagnosis of nephropathy
* Chronic gastrointestinal disorders
* Systemic inflammatory diseases
* Suspicion, clinical diagnosis or previous history of cancer (\<5 years)
* Autoimmune disorders or history of chronic and systemic autoimmune disorders
* Neurodegenerative disorders
* Pregnancy and breastfeeding
* Hormonal and / or intrauterine contraceptive therapy
* Healthcare workers
* Operators work with animals
* Psychiatric conditions that reduce protocol compliance.
POPULATION 2 - PATIENTS WITH RECIDIVING CERVIC VAGINITIS/ POPULATION 3 - PATIENTS WITH ENDOMETRIOSIS/ POPULATION 4 - PATIENTS WITH REPEATED IMPLANT FAILURES (RIF)
* Current or previous infectious diseases (HAV, HBV, HCV, HIV, Cytomegalovirus, Epstein-Barr virus)
* Chronic liver disease
* History of Clostridium difficile infections
* Recent (\<3 months) therapy with antibiotics, immunosuppressive drugs, chemotherapy
* Chronic therapy with proton pump inhibitors
* Recent (\<3 months) use of probiotics, laxatives or other aids (drugs / supplements) for the regulation of gastrointestinal activity
* Previous history of organ / tissue transplantation
* Recent onset of diarrhea
* Chronic diarrhea
* Chronic constipation
* Previous gastrointestinal surgery (eg gastric bypass)
* Recurring urinary tract infections (3 cases per year)
* Previous major acute cardiovascular diseases (myocardial infarction, stroke)
* Type 2 diabetes mellitus
* Hypertension
* eGFR (estimated glomerular filtration rate) lower than 60ml / minute and / or diagnosis of nephropathy
* Chronic gastrointestinal disorders
* Systemic inflammatory diseases
* Suspicion, clinical diagnosis or previous history of cancer (\<5 years)
* Autoimmune disorders or history of chronic and systemic autoimmune disorders
* Neurodegenerative disorders
* Pregnancy and breastfeeding
* Hormonal and / or intrauterine contraceptive therapy
* Healthcare workers
* Operators work with animals
* Psychiatric conditions that reduce protocol compliance.
18 Years
45 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies
OTHER
Istituti Tumori Giovanni Paolo II
NETWORK
University of Bari Aldo Moro
OTHER
University of Salento
OTHER
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ettore Cicinelli
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dipartimento di Scienze biomediche e oncologia umana (DIMO), Sezione di Ginecologia ed Ostetricia II Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari
Bari, , Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Ma D, Chen Y, Chen T. Vaginal microbiota transplantation for the treatment of bacterial vaginosis: a conceptual analysis. FEMS Microbiol Lett. 2019 Feb 1;366(4):fnz025. doi: 10.1093/femsle/fnz025.
Yuan M, Li D, Zhang Z, Sun H, An M, Wang G. Endometriosis induces gut microbiota alterations in mice. Hum Reprod. 2018 Apr 1;33(4):607-616. doi: 10.1093/humrep/dex372.
Smith SB, Ravel J. The vaginal microbiota, host defence and reproductive physiology. J Physiol. 2017 Jan 15;595(2):451-463. doi: 10.1113/JP271694. Epub 2016 May 5.
Laschke MW, Menger MD. The gut microbiota: a puppet master in the pathogenesis of endometriosis? Am J Obstet Gynecol. 2016 Jul;215(1):68.e1-4. doi: 10.1016/j.ajog.2016.02.036. Epub 2016 Feb 18.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BIOMIS-DIMO
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.