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Clinical Trials/NCT03460392
NCT03460392
Unknown
Not Applicable

Study of Human Microbiota in Healthy and Pathological Conditions

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio1 site in 1 country30 target enrollmentJune 12, 2017

Overview

Phase
Not Applicable
Intervention
Antibiotic therapy
Conditions
Microbial Colonization
Sponsor
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Enrollment
30
Locations
1
Primary Endpoint
Bacterial abundances calculated by mean of Operational Taxonomic Unit (OTU) count
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 12, 2017
End Date
December 31, 2019
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Responsible Party
Sponsor

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;

Arms & Interventions

Neurological and behavioral disorders

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

Intervention: Antibiotic therapy

Subjects affected by bone diseases

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

Intervention: Antibiotic therapy

Prolonged antibiotic therapy

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

Intervention: Antibiotic therapy

Outcomes

Primary Outcomes

Bacterial abundances calculated by mean of Operational Taxonomic Unit (OTU) count

Time Frame: Up to 24 weeks

It is a measure of the bacterial amount

Secondary Outcomes

  • 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)
  • Shannon's index estimated on the total OTU amount(Up to 24 weeks)
  • Simpson's index (D) estimated on the total OTU amount(Up to 24 weeks)
  • Chao's indices estimated on the total OTU amount(Up to 24 weeks)

Study Sites (1)

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