Establishment of the Human Intestinal and Salivary Microbiota Biobank - Gynecological Diseases

NCT04698109 | Completed

• 1 other identifier: BIOMIS-DIMO
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Cervicovaginitis; Endometriosis; Repeated Implantation Failure

Keywords

Microbioma biobank; Biological human samples; genital system disease; Meta-omics approaches; Microbiota-pathology relationship

Outcome Measures

Primary Outcomes (1)

• Biological samples collection for establishment of the first National Microbiome Biobank

  Recruitment of 100 subjects (patients with recurrent cervicovaginitis, endometriosis, repeated implantation failures and healthy volunteers) to collect biological samples for establishment of the first National Microbiome Biobank

  through study completion, an average of 1 year

Study Arms (4)

recurrent cervicovaginitis

patients with recurrent cervicovaginitis

Other: Biological sample collection; Other: Questionnaire; Other: Medical examination

endometriosis

patients with endometriosis

Other: Biological sample collection; Other: Questionnaire; Other: Medical examination

repeated implantation failures

patients with repeated implantation failures

Other: Biological sample collection; Other: Questionnaire; Other: Medical examination

healthy volunteers

healthy volunteers

Other: Biological sample collection; Other: Questionnaire; Other: Medical examination

Interventions

Biological sample collection OTHER

Collection of faeces, urine, saliva, vaginal swab for biobanking, to evaluate the proteomic, metascriptomic, metabolomic, metagenomic, and metagenetic profile, and to perform routine screening

endometriosis; healthy volunteers; recurrent cervicovaginitis; repeated implantation failures

Questionnaire OTHER

Anamnestic questionnaire, 3-day food questionnaire, Food Frequency Questionnaire

endometriosis; healthy volunteers; recurrent cervicovaginitis; repeated implantation failures

Medical examination OTHER

Blood pressure measurement, abdominal and thoracic physical examination

endometriosis; healthy volunteers; recurrent cervicovaginitis; repeated implantation failures

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of recurrent cervicovaginitis, of endometriosis and subjects with repeated implantation failures attending to the clinical centres involved in the study. Healthy volunteers will be recruited by invitation. Enrolled subjects must not have any family relationship and hierarchical subordination with the hospitals in which biological samples will be collected.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari: lead
• Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies: collaborator
• Istituti Tumori Giovanni Paolo II: collaborator
• University of Bari Aldo Moro: collaborator
• University of Salento: collaborator

Study Sites (1)

Dipartimento di Scienze biomediche e oncologia umana (DIMO), Sezione di Ginecologia ed Ostetricia II Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari

Bari, Italy

Location

Related Publications (4)

• 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.

  PMID: 30715301 BACKGROUND

• 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.

  PMID: 29462324 BACKGROUND

• 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.

  PMID: 27373840 BACKGROUND

• 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.

  PMID: 26901277 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

faeces, saliva, vaginal swab, urine

MeSH Terms

Conditions

Endometriosis

Interventions

Surveys and Questionnaires; Independent Medical Evaluation

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ettore Cicinelli

  Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: January 6, 2021
• Study Start: February 11, 2021
• Primary Completion: April 8, 2022
• Study Completion: April 8, 2022
• Last Updated: August 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)