Quantification of Microbiota in Health and Diseases

NCT ID: NCT03388424

Last Updated: 2020-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-22

Study Completion Date

2022-11-21

Brief Summary

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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

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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

Conditions

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Disease

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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Control

Healthy people of both sex

quantification of microbiota

Intervention Type DIAGNOSTIC_TEST

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

quantification of microbiota in Brain

Patients of both sex with neural disorders and diseases

quantification of microbiota

Intervention Type DIAGNOSTIC_TEST

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

quantification of microbiota in GI

Patients of both sex with gastrointestinal diseases

quantification of microbiota

Intervention Type DIAGNOSTIC_TEST

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

quantification of microbiota in Lung

Patients of both sex with Respiratory diseases

quantification of microbiota

Intervention Type DIAGNOSTIC_TEST

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

quantification of microbiota Metabolic

Patients of both sex with Metabolic Diseases

quantification of microbiota

Intervention Type DIAGNOSTIC_TEST

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

quantification of microbiota in UG

Patients of both sex with Uro-genital Diseases

quantification of microbiota

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Azienda Sanitaria Provinciale Di Catanzaro

OTHER

Sponsor Role collaborator

University of Catanzaro

OTHER

Sponsor Role lead

Responsible Party

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Luca Gallelli

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luca Gallelli, MD

Role: PRINCIPAL_INVESTIGATOR

University of Catanzaro

Locations

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AO Materdomini

Catanzaro, Italia, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Luca Gallelli, MD

Role: CONTACT

+390961712322

Facility Contacts

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Luca Gallelli, MD

Role: primary

+390961712537

Other Identifiers

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Microbiota2018

Identifier Type: -

Identifier Source: org_study_id

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