Quantification of Microbiota in Health and Diseases

• Conditions: Disease

• Registration Number: NCT03388424
• Lead Sponsor: University of Catanzaro

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

Study Timeline

• Study Start: 2017-11-22
• Study First Submitted: 2017-12-22
• Study First Submitted QC: 2017-12-22
• Study First Posted: 2018-01-03
• Primary Completion: 2020-05-21
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-11
• Last Update Posted: 2020-09-16
• Study Completion: 2022-11-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determination of microbiota percentage	12 months	we will determine the difference of microbiota percentage in diseases-groups respect to control-group

Secondary Outcome Measures

Name	Time	Method
Determination of antibiotic resistance gene	12 months	it will be evaluate the presence of antibiotic resistance gene in diseases-group respect to control-group

Trial Locations

Locations (1)

AO Materdomini; 🇮🇹 Catanzaro, Italia, Italy