Clinical trial NCT03460392: Study of Human Microbiota in Healthy and Pathological Conditions
Official title: Study of Human Microbiota in Healthy and Pathological Conditions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Microbial Colonization
Keywords: Human microbiota
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2018-03-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For each cohoort 15 healthy subjects will be enrolled (controls), for a total of 90 subjects.

The study involves the recruitment of 180 subjects (90 pathological and 90 healthy and recruited

Brief 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

Detailed 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.

Eligibility criteria: 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;

Primary outcomes:
measure: Bacterial abundances calculated by mean of Operational Taxonomic Unit (OTU) count
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Chao's indices estimated on the total OTU amount
timeFrame: Up to 24 weeks
measure: Simpson's index (D) estimated on the total OTU amount
timeFrame: Up to 24 weeks
measure: Shannon's index estimated on the total OTU amount
timeFrame: Up to 24 weeks
measure: The OTU abundances will be used to calculate an adjacency matrix based on the Spearman's correlation coefficient (rs) among different bacterial genus
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
state: MI
Study officials:
affiliation: IRCCS Galeazzi Orthopedic Institute, Milan, Italy
name: Lorenzo Drago, Prof.
role: PRINCIPAL_INVESTIGATOR
References: