Study of Human Microbiota in Healthy and Pathological Conditions (MicroSP)

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Status: Unknown

Conditions: Microbial Colonization

Treatments: Drug: Antibiotic therapy

Study type: Observational

Funder types: Other

Identifiers

NCT03460392

MiscoSP

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

30 participants in 7 patient groups

Neurological and behavioral disorders

Description:

Subjects with neurological or behavioral disorders such as Tourette syndrome are enrolled.

Treatment:

Drug: Antibiotic therapy

Subjects affected by bone diseases

Description:

Subjects affected by bone diseases such as infective osteomyelitis or osteoporosis are enrolled.

Treatment:

Drug: Antibiotic therapy

Dysmetabolic and/or endocrine disorders

Description:

Patients with endocrine disorders, such as thyroid disfunctions, or with metabolic disorders, including diabetes mellitus,are enrolled.

Subjects performing agonistic activity

Description:

Subjects performing physical activity at agonistic level are enrolled.

Gastroenteric disorders

Description:

Subjects affected by gastric and/or enteric disorders are enrolled.

Prolonged antibiotic therapy

Description:

Patients subjected to prolonged antibiotic therapies and undergone a variety of surgical procedures are enrolled.

Treatment:

Drug: Antibiotic therapy

Healthy subjects

Description:

Subjects without any known ongoing disease are enrolled.