Establishment of the Human Intestinal and Salivary Microbiota Biobank - Obesity

NCT04698135 | Completed

• 1 other identifier: BIOMIS-Endo
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, clinical, multicentre study aimed to collect biological samples and study microbiota from subjects with morbid obesity, metabolically healthy obesity 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 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

Morbid Obesity; Metabolically Healthy Obesity

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  Recruitment of 60 subjects (morbid obesity, metabolically healthy obesity 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 (3)

morbid obesity

Patients with morbid obesity

Other: Biological samples collection; Other: Questionnaire; Other: Medical/laboratory examinations

Metabolically healthy obesity

Patients with metabolically healthy obesity

Other: Biological samples collection; Other: Questionnaire; Other: Medical/laboratory examinations

Healthy volunteers

Healthy volunteers

Other: Biological samples collection; Other: Questionnaire; Other: Medical/laboratory examinations

Interventions

Biological samples collection OTHER

Collection of faeces, coproculture examination, urine, saliva, PBMC and blood for biobanking, to evaluate the proteomic, metascriptomic, metabolomic, metagenomic, and metagenetic profile, and to perform routine screening. Analysis for the identification, quantification and characterization of health-promoting bacteria

Healthy volunteers; Metabolically healthy obesity; morbid obesity

Questionnaire OTHER

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

Healthy volunteers; Metabolically healthy obesity; morbid obesity

Medical/laboratory examinations OTHER

Blood pressure measurement, abdominal and thoracic physical examination, body composition through bioimpedance analysis and metabolic, cardiovascular and respiratory variables; OGTT 75gr for blood glucose and insulin at times 0, 30, 60, 90 and 120', and a nocturnal oximetry and subsequently, if necessary, overnight polysomnography for the diagnosis of obstructive sleep

Healthy volunteers; Metabolically healthy obesity; morbid obesity

Eligibility Criteria

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

Study Population

Subjects with morbid obesity and metabolically healthy obesityattending one of 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 60 years
• BMI between 18.5-30
• omnivorous diet
• signature of the informed consent
• SUBJECTS WITH MORBID OBESITY
• subjects aged between 18 and 60 years
• subjects having morbid obesity (BMI ≥ 35 kg/m2), as following at least two of the following conditions: insulin resistance, prediabetes or type 2 diabetes mellitus, dyslipidemia, cardiovascular (arterial hypertension) and respiratory (obstructive sleep apnea) diseases
• omnivorous diet
• signature of the informed consent
• SUBJECTS WITH METABOLICALLY HEALTHY OBESITY
• subjects aged between 18 and 60 years
• Obese subjects (BMI ≥ 35 kg/m2) metabolically healthy, without or with only one of the following : insulin resistance, prediabetes or type 2 diabetes mellitus, dyslipidemia, cardiovascular (arterial hypertension) and respiratory (obstructive sleep apnea) diseases
• omnivorous diet
• signature of the informed consent

You may not qualify if:

• HEALTHY VOLUNTEERS/SUBJECTS WITH MORBID OBESITY/ METABOLICALLY HEALTHY OBESITY
• 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
• University of Bari Aldo Moro: collaborator
• University of Salento: collaborator
• Istituti Tumori Giovanni Paolo II: collaborator
• Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies: collaborator

Study Sites (1)

Azienda Ospedaliera Universitaria Policlinico di Bari - U.O.C. Endocrinologia Universitaria (D.E.T.O.)

Bari, Italy

Location

Related Publications (5)

• Zhang Z, Mocanu V, Cai C, Dang J, Slater L, Deehan EC, Walter J, Madsen KL. Impact of Fecal Microbiota Transplantation on Obesity and Metabolic Syndrome-A Systematic Review. Nutrients. 2019 Sep 25;11(10):2291. doi: 10.3390/nu11102291.

  PMID: 31557953 BACKGROUND

• Aron-Wisnewsky J, Clement K, Nieuwdorp M. Fecal Microbiota Transplantation: a Future Therapeutic Option for Obesity/Diabetes? Curr Diab Rep. 2019 Jun 27;19(8):51. doi: 10.1007/s11892-019-1180-z.

  PMID: 31250122 BACKGROUND

• Chen X, Devaraj S. Gut Microbiome in Obesity, Metabolic Syndrome, and Diabetes. Curr Diab Rep. 2018 Oct 18;18(12):129. doi: 10.1007/s11892-018-1104-3.

  PMID: 30338410 BACKGROUND

• Kang Y, Cai Y. Gut microbiota and obesity: implications for fecal microbiota transplantation therapy. Hormones (Athens). 2017 Jul;16(3):223-234. doi: 10.14310/horm.2002.1742.

  PMID: 29278509 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

Biospecimen

Retention: SAMPLES WITH DNA

faeces, saliva, blood, serum, urine, PBMC

MeSH Terms

Conditions

Obesity, Morbid; Obesity, Metabolically Benign; Obesity

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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

• Francesco Giorgino, 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: March 25, 2021
• Primary Completion: June 9, 2022
• Study Completion: July 30, 2022
• Last Updated: January 13, 2023

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)