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Study of Human Microbiota in Healthy and Pathological Conditions

Study of Human Microbiota in Healthy and Pathological Conditions

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03460392
Acronym
MicroSP
Enrollment
30
Registered
2018-03-09
Start date
2017-06-12
Completion date
2019-12-31
Last updated
2018-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microbial Colonization

Keywords

Human microbiota

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.

Interventions

DRUGAntibiotic therapy

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

Sponsors

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

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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;

Design outcomes

Primary

MeasureTime frameDescription
Bacterial abundances calculated by mean of Operational Taxonomic Unit (OTU) countUp to 24 weeksIt is a measure of the bacterial amount

Secondary

MeasureTime frameDescription
Chao's indices estimated on the total OTU amountUp to 24 weeksIt is a measure of bacterial diversity
Simpson's index (D) estimated on the total OTU amountUp to 24 weeksIt is a measure of bacterial diversity
Shannon's index estimated on the total OTU amountUp to 24 weeksIt 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 genusup to 24 weeksIt is a measure of strength of linear association between different bacterial genera

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026