Quantification of Microbiota in Health and Diseases

NCT03388424 | Unknown

• 1 other identifier: Microbiota2018
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Disease

Keywords

bacterial DNA, RNA16S gene

Outcome Measures

Primary Outcomes (1)

• Determination of microbiota percentage

  we will determine the difference of microbiota percentage in diseases-groups respect to control-group

  12 months

Secondary Outcomes (1)

• Determination of antibiotic resistance gene

  12 months

Study Arms (6)

Control

Healthy people of both sex

Diagnostic Test: quantification of microbiota

quantification of microbiota in Brain

Patients of both sex with neural disorders and diseases

Diagnostic Test: quantification of microbiota

quantification of microbiota in GI

Patients of both sex with gastrointestinal diseases

Diagnostic Test: quantification of microbiota

quantification of microbiota in Lung

Patients of both sex with Respiratory diseases

Diagnostic Test: quantification of microbiota

quantification of microbiota Metabolic

Patients of both sex with Metabolic Diseases

Diagnostic Test: quantification of microbiota

quantification of microbiota in UG

Patients of both sex with Uro-genital Diseases

Diagnostic Test: quantification of microbiota

Interventions

quantification of microbiota 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

Control; quantification of microbiota Metabolic; quantification of microbiota in Brain; quantification of microbiota in GI; quantification of microbiota in Lung; quantification of microbiota in UG

Eligibility Criteria

• Age: 4 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Patients who will not sign the informed consent

Sponsors & Collaborators

• University of Catanzaro: lead
• Azienda Sanitaria Provinciale Di Catanzaro: collaborator

Study Sites (1)

AO Materdomini

Catanzaro, Italia, 88100, Italy

RECRUITING

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Luca Gallelli, MD

  University of Catanzaro

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luca Gallelli, MD

CONTACT

+390961712322; gallelli@unicz.it

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 22, 2017
• First Posted: January 3, 2018
• Study Start: November 22, 2017
• Primary Completion: May 21, 2020
• Study Completion: November 21, 2022
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)