Quantification of Microbiota in Health and Diseases (qMHD)

September 11, 2020 updated by: Luca Gallelli, University of Catanzaro
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Italia
      • Catanzaro, Italia, Italy, 88100
        • Recruiting
        • AO Materdomini

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
Healthy people of both sex
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
quantification of microbiota in Brain
Patients of both sex with neural disorders and 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
quantification of microbiota in GI
Patients of both sex with gastrointestinal 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
quantification of microbiota in Lung
Patients of both sex with Respiratory 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
quantification of microbiota Metabolic
Patients of both sex with Metabolic 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
quantification of microbiota in UG
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of microbiota percentage
Time Frame: 12 months
we will determine the difference of microbiota percentage in diseases-groups respect to control-group
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of antibiotic resistance gene
Time Frame: 12 months
it will be evaluate the presence of antibiotic resistance gene in diseases-group respect to control-group
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Catanzaro

Collaborators

Azienda Sanitaria Provinciale Di Catanzaro

Investigators

  • Principal Investigator: Luca Gallelli, MD, University of Catanzaro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2017

Primary Completion (Actual)

May 21, 2020

Study Completion (Anticipated)

November 21, 2022

Study Registration Dates

First Submitted

December 22, 2017

First Submitted That Met QC Criteria

December 22, 2017

First Posted (Actual)

January 3, 2018

Study Record Updates

Last Update Posted (Actual)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 11, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Microbiota2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

data will kept in hospital and results will be published

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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