Study of Human Microbiota in Healthy and Pathological Conditions

Microbial Colonization Clinical Trial

— MicroSP  

Official title:

Study of Human Microbiota in Healthy and Pathological Conditions

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03460392
• Other study ID #: MiscoSP
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 15, 2018
• Last updated: March 2, 2018
• Start date: June 12, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2018
• Source: Istituto Ortopedico Galeazzi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The aim of the present study is to characterize the bacterial composition (microbiota) colonizing to the human body in different physio - pathological conditions (lifestyle, motor activity, surgical operations, probiotic and prebiotic consumption, antibiotic therapies, chemotherapeutic therapies), nervous and musculoskeletal diseases, gastrointestinal and metabolic disorders , oral and vaginal diseases, etc.). In particular, they will be investigate:

• the changes in the bacterial abundance

• the potential microbial interactions with the human host

• the microbial networks describing on the bacterial interactions within a specific composition of the human microbiota

Description:

The main objective of this study is to deepen the knowledge about the bacterial communities associated to the human organism. In particular, the present study aims to evaluate how the microbiota (intestinal, cutaneous, vaginal, nasal, bronchial, breast milk, salivary, oral, etc.) is subject to quantitative and qualitative changes consequently to different events involving the human host. The project trys to highlight which microorganisms may be involved in the onset or progression of certain pathological condition, as well as to identify which bacterial genera can be more subject to variations due to specific non-pathological events.

Secondary objectives of this study are:

• To define a "healthy microbiome", that is to understand which are the main bacteria that commonly compose the human microbiome in physiological conditions, differentiating it from that present in certain pathological conditions.

• To characterize the physiological effects that bacterial changes of the human microbiota have on the host.

• To evaluate whether the use of probiotics, prebiotics, dietary and nutritional factors, cosmetics, and oral, nasal, vaginal, or pharmacological therapies of any kind can influence the microbial network of the human microbiota associated to different body districts.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: December 31, 2019
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• subjects suffering from neurological/behavioral diseases;

• subjects suffering of bone diseases;

• subjects affected of dysmetabolic / or endocrine disorders;

• subjects with physical activities at a competitive level;

• subjects affected of gastrointestinal disorders;

• subjects with prolonged antibiotic therapies and undergoing surgery

Exclusion Criteria:

• no use of probiotics in the month prior the sampling;

• no use of antibiotics in the month prior the sampling;

• no consumption of yogurt in the month prior the sampling;

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Microbial Colonization

Intervention

Drug:
• Antibiotic therapy
To evaluate the effects of a specific event (i.e. surgical operation) or therapy (i.e antibiotic treatment) over time;

Locations

Country	Name	City	State
Italy	IRCCS Istituto Ortopedico Galeazzi	Milan	MI

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacterial abundances calculated by mean of Operational Taxonomic Unit (OTU) count	It is a measure of the bacterial amount	Up to 24 weeks
Secondary	Chao's indices estimated on the total OTU amount	It is a measure of bacterial diversity	Up to 24 weeks
Secondary	Simpson's index (D) estimated on the total OTU amount	It is a measure of bacterial diversity	Up to 24 weeks
Secondary	Shannon's index estimated on the total OTU amount	It is a measure of bacterial diversity	Up to 24 weeks
Secondary	The OTU abundances will be used to calculate an adjacency matrix based on the Spearman's correlation coefficient (rs) among different bacterial genus	It is a measure of strength of linear association between different bacterial genera	up to 24 weeks