Establishment of the Human Intestinal and Salivary Microbiota Biobank - Metabolic Syndrome

NCT ID: NCT04698096

Last Updated: 2022-03-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-20
• Study Completion Date: 2022-03-07

Brief Summary

This is a prospective, clinical, monocentric study aimed to collect biological samples and study microbiota from subjects suffering from metabolic syndrome 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, blood, urine) from healthy volunteers and patients suffering from chronic renal diseases 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.

Detailed Description

The primary aim of this multicentric study is to populate the first national microbioma biobank with biological samples (fecal, salivary, urinary and blood samples) subjects suffering from metabolic syndrome, and healthy volunteers.

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 35 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), anthropometric measurements (weight, height, BMI, abdominal circumference measurement), 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 blood sampling 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

Metabolic Syndrome

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

metabolic syndrome

Patients with metabolic syndrome

Questionnaire

Intervention Type: OTHER

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

Medical examination

Intervention Type: OTHER

Blood pressure measurement, abdominal and thoracic physical examination

Biological sample collection

Intervention Type: OTHER

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

Healthy volunteers

Healthy volunteers

Questionnaire

Intervention Type: OTHER

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

Medical examination

Intervention Type: OTHER

Blood pressure measurement, abdominal and thoracic physical examination

Biological sample collection

Intervention Type: OTHER

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

Interventions

Questionnaire

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

Intervention Type: OTHER

Medical examination

Blood pressure measurement, abdominal and thoracic physical examination

Intervention Type: OTHER

Biological sample collection

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

HEALTHY VOLUNTEERS

• healthy subjects aged between 18 and 60 years
• BMI between 18.5-30
• omnivorous diet
• signature of the informed consent

PATIENTS WITH METABOLIC SYNDROME

• age between 18 and 60 years
• patients with metabolic syndrome defined as follows:
• abdominal circumference > 94cm (males), > 80cm (females)
• presence of at least 2 of the following 4 criteria:

1. triglycerides 150 mg / dl or in specific treatment

2. HDL cholesterol <40mg / dI in women and <50mg / dl in men

3. blood pressure values> 130/85 mmHg or hypertension under treatment

4. fasting blood glucose 100 mg / dl or diabetes already diagnosed

• omnivorous diet
• signature of the informed consent

Exclusion Criteria

HEALTHY VOLUNTEERS and PATIENTS WITH METABOLIC SYNDROME

• 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
• Healthcare workers
• Operators work with animals
• Psychiatric conditions that reduce protocol compliance.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies

OTHER

Sponsor Role: collaborator

Istituti Tumori Giovanni Paolo II

NETWORK

Sponsor Role: collaborator

University of Salento

OTHER

Sponsor Role: collaborator

University of Bari Aldo Moro

OTHER

Sponsor Role: collaborator

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio Moschetta, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari

Locations

Azienda Ospedaliera Universitaria Policlinico di Bari - Dipartimento Interdisciplinare di Medicina

Bari, , Italy

Countries

Italy

References

Zhou Y, Xu H, Huang H, Li Y, Chen H, He J, Du Y, Chen Y, Zhou Y, Nie Y. Are There Potential Applications of Fecal Microbiota Transplantation beyond Intestinal Disorders? Biomed Res Int. 2019 Jul 29;2019:3469754. doi: 10.1155/2019/3469754. eCollection 2019.

Reference Type: BACKGROUND

PMID: 31467881 (View on PubMed)

de Groot PF, Frissen MN, de Clercq NC, Nieuwdorp M. Fecal microbiota transplantation in metabolic syndrome: History, present and future. Gut Microbes. 2017 May 4;8(3):253-267. doi: 10.1080/19490976.2017.1293224. Epub 2017 Feb 27.

Reference Type: BACKGROUND

PMID: 28609252 (View on PubMed)

Marotz CA, Zarrinpar A. Treating Obesity and Metabolic Syndrome with Fecal Microbiota Transplantation. Yale J Biol Med. 2016 Sep 30;89(3):383-388. eCollection 2016 Sep.

Reference Type: BACKGROUND

PMID: 27698622 (View on PubMed)

Festi D, Schiumerini R, Eusebi LH, Marasco G, Taddia M, Colecchia A. Gut microbiota and metabolic syndrome. World J Gastroenterol. 2014 Nov 21;20(43):16079-94. doi: 10.3748/wjg.v20.i43.16079.

Reference Type: BACKGROUND

PMID: 25473159 (View on PubMed)

Degirolamo C, Rainaldi S, Bovenga F, Murzilli S, Moschetta A. Microbiota modification with probiotics induces hepatic bile acid synthesis via downregulation of the Fxr-Fgf15 axis in mice. Cell Rep. 2014 Apr 10;7(1):12-8. doi: 10.1016/j.celrep.2014.02.032. Epub 2014 Mar 20.

Reference Type: BACKGROUND

PMID: 24656817 (View on PubMed)

Petruzzelli M, Moschetta A. Intestinal ecology in the metabolic syndrome. Cell Metab. 2010 May 5;11(5):345-6. doi: 10.1016/j.cmet.2010.04.012.

Reference Type: BACKGROUND

PMID: 20444415 (View on PubMed)

Other Identifiers

BIOMIS-DIM

Identifier Type: -

Identifier Source: org_study_id