Study of Human Microbiota in Healthy and Pathological Conditions

NCT ID: NCT03460392

Last Updated: 2018-03-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-12
• Study Completion Date: 2019-12-31

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.

Conditions

Microbial Colonization

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Neurological and behavioral disorders

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

Antibiotic therapy

Intervention Type: DRUG

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

Subjects affected by bone diseases

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

Antibiotic therapy

Intervention Type: DRUG

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

Dysmetabolic and/or endocrine disorders

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

No interventions assigned to this group

Subjects performing agonistic activity

Subjects performing physical activity at agonistic level are enrolled.

No interventions assigned to this group

Gastroenteric disorders

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

No interventions assigned to this group

Prolonged antibiotic therapy

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

Antibiotic therapy

Intervention Type: DRUG

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

Healthy subjects

Subjects without any known ongoing disease are enrolled.

No interventions assigned to this group

Interventions

Antibiotic therapy

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

Intervention Type: DRUG

Other Intervention Names

Probiotics, dietary factors, cosmetics and adjuvants

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lorenzo Drago, Prof.

Role: PRINCIPAL_INVESTIGATOR

IRCCS Galeazzi Orthopedic Institute, Milan, Italy

Locations

IRCCS Istituto Ortopedico Galeazzi

Milan, MI, Italy

Countries

Italy

Other Identifiers

MiscoSP

Identifier Type: -

Identifier Source: org_study_id