Morbid Obesity Clinical Trial
— BIOMIS-EndoOfficial title:
Costituzione Della Biobanca Del Microbiota Intestinale e Salivare Umano: Dalla Disbiosi Alla Simbiosi
NCT number | NCT04698135 |
Other study ID # | BIOMIS-Endo |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 25, 2021 |
Est. completion date | July 30, 2022 |
Verified date | January 2022 |
Source | Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 59 |
Est. completion date | July 30, 2022 |
Est. primary completion date | June 9, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: 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 - Exclusion Criteria: 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 - 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. |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedaliera Universitaria Policlinico di Bari - U.O.C. Endocrinologia Universitaria (D.E.T.O.) | Bari |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari | Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies, Istituti Tumori Giovanni Paolo II, University of Bari Aldo Moro, University of Salento |
Italy,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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