Clinical trial NCT03388424: Quantification of Microbiota in Health and Diseases
Official title: Quantification of Microbiota in Health and Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Disease
Keywords: bacterial DNA, RNA16S gene
Lead sponsor: University of Catanzaro
Sponsor class: OTHER
Collaborators: name: Azienda Sanitaria Provinciale Di Catanzaro
First posted: 2018-01-03
Enrollment: 120
Sex: ALL
Minimum age (years): 4
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* all patients will be enclosed in each group in agreement with the characteristics of the groups

Exclusion Criteria:

* Patients who will not sign the informed consent

Primary outcomes:
measure: Determination of microbiota percentage
timeFrame: 12 months
Secondary outcomes:
measure: Determination of antibiotic resistance gene
timeFrame: 12 months
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: AO Materdomini
state: Italia
Study officials:
affiliation: University of Catanzaro
name: Luca Gallelli, MD
role: PRINCIPAL_INVESTIGATOR
References: