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

NCT04698096 | Completed

• 1 other identifier: BIOMIS-DIM
• Study Type: observational
• Target: 40
• 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 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.

Conditions

Metabolic Syndrome

Keywords

Microbioma biobank; Biological human samples; metabolic syndrome; Meta-omics approaches; Microbiota-pathology relationship

Outcome Measures

Primary Outcomes (1)

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

  Recruitment of 35 subjects with metabolic syndrome and from healthy volunteers to collect biological samples for establishment of the first National Microbiome Biobank

  through study completion, an average of 1 year

Study Arms (2)

metabolic syndrome

Patients with metabolic syndrome

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, and blood for biobanking, to evaluate the proteomic, metascriptomic, metabolomic, metagenomic, and metagenetic profile, and to perform routine screening

Healthy volunteers; metabolic syndrome

Questionnaire OTHER

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

Healthy volunteers; metabolic syndrome

Medical examination OTHER

Blood pressure measurement, abdominal and thoracic physical examination

Healthy volunteers; metabolic syndrome

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of metabolic syndrome attending the clinical centre 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 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:
• triglycerides 150 mg / dl or in specific treatment
• HDL cholesterol \<40mg / dI in women and \<50mg / dl in men
• blood pressure values\> 130/85 mmHg or hypertension under treatment
• fasting blood glucose 100 mg / dl or diabetes already diagnosed
• omnivorous diet

You may not qualify if:

• 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

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 Salento: collaborator
• University of Bari Aldo Moro: collaborator

Study Sites (1)

Azienda Ospedaliera Universitaria Policlinico di Bari - Dipartimento Interdisciplinare di Medicina

Bari, Italy

Location

Related Publications (6)

• 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.

  PMID: 31467881 BACKGROUND

• 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.

  PMID: 28609252 BACKGROUND

• 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.

  PMID: 27698622 BACKGROUND

• 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.

  PMID: 25473159 BACKGROUND

• 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.

  PMID: 24656817 BACKGROUND

• 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.

  PMID: 20444415 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

faeces, saliva, blood, serum, urine

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Surveys and Questionnaires; Independent Medical Evaluation

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic 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

• Antonio Moschetta, MD

  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: July 20, 2021
• Primary Completion: March 7, 2022
• Study Completion: March 7, 2022
• Last Updated: March 24, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)