Quantification of Microbiota in Health and Diseases

Disease Clinical Trial

— qMHD  

Official title:

Quantification of Microbiota in Health and Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03388424
• Other study ID #: Microbiota2018
• Status: Recruiting
• Start date: November 22, 2017
• Est. completion date: November 21, 2022

Study information

• Verified date: September 2020
• Source: University of Catanzaro
• Contact: Luca Gallelli, MD
• Phone: +390961712322
• Email: gallelli[@]unicz.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: November 21, 2022
• Est. primary completion date: May 21, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease

Intervention

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

Locations

Country	Name	City	State
Italy	AO Materdomini	Catanzaro	Italia

Sponsors (2)

Lead Sponsor	Collaborator
University of Catanzaro	Azienda Sanitaria Provinciale Di Catanzaro

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of microbiota percentage	we will determine the difference of microbiota percentage in diseases-groups respect to control-group	12 months
Secondary	Determination of antibiotic resistance gene	it will be evaluate the presence of antibiotic resistance gene in diseases-group respect to control-group	12 months