An observational study in Disease, sponsored by University of Catanzaro. Status unknown at 1 site in Italy. Open to participants aged 4 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-16.
Sponsored by University of Catanzaro · Observational
Microbiota consists of trillions of microorganisms located in all the biological cavity. The relationships between individual health status and microbiota are based on a sort of "mutual cooperation." The balance of the microbiota can be compromised by various factors such as environmental, psycho-physical stress, malnutrition (over or low), breastfeeding, chronic diseases, oncology and pharmacological treatments (especially antibiotics and chemotherapics). The impact of dysbiosis on today's society affects over 70% of the world population
Intestinal microbiota is defined as the strongest modulator of the human genome and it is considered the "second brain" of our organism for its bi-directional communication with the central nervous system. Microbiota consists of trillions of microorganisms located in all the biological cavity, In the intestine it is distributed in ecological niches having multiple metabolic activities which influence individual health. Microbiota acts as barrier against pathogens, regulating the absorption of nutrients, the production of energy and the development of the immune system4. Intestinal bacteria are generally divided into 4 Phylum: Firmicutes, Actinobacteria, Proteobacteria and Bacteriodetes, in which their proportion shows a correlation with individuals health status. When in equilibrium among them, these bacteria are essential for the good health of the digestive tract, the good function of immune system and for brain performace. The relationships between individual health status and microbiota are based on a sort of "mutual cooperation." The balance of the microbiota can be compromised by various factors such as environmental, psycho-physical stress, malnutrition (over or low), breastfeeding, chronic diseases, oncology and pharmacological treatments (especially antibiotics and chemotherapics). This disequilibrium leads to altered capability of bacteria to properly extract calories from food affecting the trend of many pathophisilogical status such as obesity, allergic states, inflammatory bowel syndromes cardiovascular diseases, metabolic, oncological and neurodegenerative diseases. The impact of dysbiosis on today's society affects over 70% of the world population
University of Catanzaro is the lead sponsor of 45 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Health and disease patients, after a detailed history will be enrolled in one of the six groups and a biological sample will be take for the examination using the n-counter platform.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy people of both sex
Diagnostic Test: quantification of microbiota
Patients of both sex with neural disorders and diseases
Diagnostic Test: quantification of microbiota
Patients of both sex with gastrointestinal diseases
Diagnostic Test: quantification of microbiota
Patients of both sex with Respiratory diseases
Diagnostic Test: quantification of microbiota
Patients of both sex with Metabolic Diseases
Diagnostic Test: quantification of microbiota
Patients of both sex with Uro-genital Diseases
Diagnostic Test: quantification of microbiota
For each group a sample of biological sample will be take and will be analyzed using the n-counter flex platform in order to quantify disbiosis
Determination of microbiota percentage
we will determine the difference of microbiota percentage in diseases-groups respect to control-group
Time frame: 12 months
Determination of antibiotic resistance gene
it will be evaluate the presence of antibiotic resistance gene in diseases-group respect to control-group
Time frame: 12 months
Plan to share: No — data will kept in hospital and results will be published
No publications or documents are linked to this record.
Ran from Nov 2017 to primary completion in May 2020, 29 months.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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University of Catanzaro