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

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

Study Overview

• Status: Unknown
• Conditions: Microbial Colonization
• Intervention / Treatment: Drug: Antibiotic therapy

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.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• Italy
  • MI
    • Milan, MI, Italy, 20161
      • IRCCS Istituto Ortopedico Galeazzi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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;

Study Plan

How is the study designed?

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Neurological and behavioral disorders; Subjects with neurological or behavioral disorders such as Tourette syndrome are enrolled.	Drug: Antibiotic therapy; To evaluate the effects of a specific event (i.e. surgical operation) or therapy (i.e antibiotic treatment) over time; Other Names: Probiotics, dietary factors, cosmetics and adjuvants
Subjects affected by bone diseases; Subjects affected by bone diseases such as infective osteomyelitis or osteoporosis are enrolled.	Drug: Antibiotic therapy; To evaluate the effects of a specific event (i.e. surgical operation) or therapy (i.e antibiotic treatment) over time; Other Names: Probiotics, dietary factors, cosmetics and adjuvants
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.	Drug: Antibiotic therapy; To evaluate the effects of a specific event (i.e. surgical operation) or therapy (i.e antibiotic treatment) over time; Other Names: Probiotics, dietary factors, cosmetics and adjuvants
Healthy subjects; Subjects without any known ongoing disease are enrolled.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Galeazzi
• Investigators: Principal Investigator: Lorenzo Drago, Prof., IRCCS Galeazzi Orthopedic Institute, Milan, Italy

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2017
• Primary Completion (Actual): July 31, 2017
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: February 15, 2018
• First Submitted That Met QC Criteria: March 2, 2018
• First Posted (Actual): March 9, 2018

Study Record Updates

• Last Update Posted (Actual): March 9, 2018
• Last Update Submitted That Met QC Criteria: March 2, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Human microbiota
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: MiscoSP