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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 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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neurological and behavioral disorders | Subjects with neurological or behavioral disorders such as Tourette syndrome are enrolled. |
| |
| Subjects affected by bone diseases | Subjects affected by bone diseases such as infective osteomyelitis or osteoporosis are enrolled. |
| |
| Dysmetabolic and/or endocrine disorders | Patients with endocrine disorders, such as thyroid disfunctions, or with metabolic disorders, including diabetes mellitus,are enrolled. | ||
| Subjects performing agonistic activity | Subjects performing physical activity at agonistic level are enrolled. | ||
| Gastroenteric disorders | Subjects affected by gastric and/or enteric disorders are enrolled. | ||
| Prolonged antibiotic therapy | Patients subjected to prolonged antibiotic therapies and undergone a variety of surgical procedures are enrolled. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antibiotic therapy | Drug | To evaluate the effects of a specific event (i.e. surgical operation) or therapy (i.e antibiotic treatment) over time; |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bacterial abundances calculated by mean of Operational Taxonomic Unit (OTU) count | It is a measure of the bacterial amount | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Chao's indices estimated on the total OTU amount | It is a measure of bacterial diversity | Up to 24 weeks |
| Simpson's index (D) estimated on the total OTU amount | It is a measure of bacterial diversity |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Lorenzo Drago, Prof. | IRCCS Galeazzi Orthopedic Institute, Milan, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Istituto Ortopedico Galeazzi | Milan | MI | 20161 | Italy |
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D019936 | Probiotics |
| D003358 | Cosmetics |
| ID | Term |
|---|---|
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D019587 | Dietary Supplements |
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| Healthy subjects | Subjects without any known ongoing disease are enrolled. |
|
| Up to 24 weeks |
| Shannon's index estimated on the total OTU amount | It is a measure of bacterial diversity | Up to 24 weeks |
| 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 |
| D005502 |
| Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D020313 | Specialty Uses of Chemicals |
| D006795 | Household Products |
| D013676 | Technology, Industry, and Agriculture |