Study of Human Microbiota in Healthy and Pathological Conditions
- Conditions
- Microbial Colonization
- Interventions
- Drug: Antibiotic therapy
- Registration Number
- NCT03460392
- Lead Sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- 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
- 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;
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Neurological and behavioral disorders Antibiotic therapy Subjects with neurological or behavioral disorders such as Tourette syndrome are enrolled. Subjects affected by bone diseases Antibiotic therapy Subjects affected by bone diseases such as infective osteomyelitis or osteoporosis are enrolled. Prolonged antibiotic therapy Antibiotic therapy Patients subjected to prolonged antibiotic therapies and undergone a variety of surgical procedures are enrolled.
- Primary Outcome Measures
Name Time Method Bacterial abundances calculated by mean of Operational Taxonomic Unit (OTU) count Up to 24 weeks It is a measure of the bacterial amount
- Secondary Outcome Measures
Name Time Method Shannon's index estimated on the total OTU amount Up to 24 weeks It is a measure of bacterial diversity
The OTU abundances will be used to calculate an adjacency matrix based on the Spearman's correlation coefficient (rs) among different bacterial genus up to 24 weeks It is a measure of strength of linear association between different bacterial genera
Simpson's index (D) estimated on the total OTU amount Up to 24 weeks It is a measure of bacterial diversity
Chao's indices estimated on the total OTU amount Up to 24 weeks It is a measure of bacterial diversity
Trial Locations
- Locations (1)
IRCCS Istituto Ortopedico Galeazzi
🇮🇹Milan, MI, Italy
IRCCS Istituto Ortopedico Galeazzi🇮🇹Milan, MI, Italy