Status:
COMPLETED
Establishment of the Human Intestinal and Salivary Microbiota Biobank - Gynecological Diseases
Lead Sponsor:
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Collaborating Sponsors:
Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies
Istituti Tumori Giovanni Paolo II
Conditions:
Cervicovaginitis
Endometriosis
Eligibility:
All Genders
18-45 years
Brief Summary
This is a prospective, clinical, monocentric study aimed to collect biological samples and study microbiota from subjects suffering from subjects with recurrent cervicovaginitis, subjects with endomet...
Detailed Description
The primary aim of this monocentric study is to populate the first national microbioma biobank with biological samples (fecal, salivary, urinary and vaginsl samples) subjects suffering from selected d...
Eligibility Criteria
Inclusion
- HEALTHY VOLUNTEERS
- 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
- Inclusion criteria:
- 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)
- Inclusion criteria:
- 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
- HEALTHY VOLUNTEERS
- 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.
- Exclusion criteria:
- 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.
Key Trial Info
Start Date :
February 11 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 8 2022
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT04698109
Start Date
February 11 2021
End Date
April 8 2022
Last Update
August 4 2022
Active Locations (1)
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1
Dipartimento di Scienze biomediche e oncologia umana (DIMO), Sezione di Ginecologia ed Ostetricia II Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari
Bari, Italy