Establishment of the Human Intestinal and Salivary Microbiota Biobank - Gynecological Diseases (NCT04698109) | Clinical Trial Compass
CompletedNot Applicable
Establishment of the Human Intestinal and Salivary Microbiota Biobank - Gynecological Diseases
Italy103 participantsStarted 2021-02-11
Plain-language 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 endometriosis, subjects with repeated implantation failures and from healthy volunteers. Microbiota is a complex consortium of microorganisms, located at the mucosal level (in particular intestinal, oral and vaginal) having a key role in human health and in the onset of several diseases. Microbiota alterations have been found in several diseases (gastrointestinal, metabolic, renal, oncological, gynaecological).
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.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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 Criteria:
HEALTHY VOLUNTEERS
* Current or previous infectious diseases (HAV, HBV, HCV, HIV, Cytomegalovirus, Epstein-Barr virus)
* HPV positive
* Chronic liver disease
* History of Clost…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Biological samples collection for establishment of the first National Microbiome Biobank
Timeframe: through study completion, an average of 1 year
Trial details
NCT IDNCT04698109
SponsorAzienda Ospedaliero-Universitaria Consorziale Policlinico di Bari