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
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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MI
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Milan、MI、イタリア、20161
- IRCCS Istituto Ortopedico Galeazzi
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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
説明
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;
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Neurological and behavioral disorders
Subjects with neurological or behavioral disorders such as Tourette syndrome are enrolled.
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To evaluate the effects of a specific event (i.e.
surgical operation) or therapy (i.e antibiotic treatment) over time;
他の名前：
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Subjects affected by bone diseases
Subjects affected by bone diseases such as infective osteomyelitis or osteoporosis are enrolled.
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To evaluate the effects of a specific event (i.e.
surgical operation) or therapy (i.e antibiotic treatment) over time;
他の名前：
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Dysmetabolic and/or endocrine disorders
Patients with endocrine disorders, such as thyroid disfunctions, or with metabolic disorders, including diabetes mellitus,are enrolled.
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Subjects performing agonistic activity
Subjects performing physical activity at agonistic level are enrolled.
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Gastroenteric disorders
Subjects affected by gastric and/or enteric disorders are enrolled.
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Prolonged antibiotic therapy
Patients subjected to prolonged antibiotic therapies and undergone a variety of surgical procedures are enrolled.
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To evaluate the effects of a specific event (i.e.
surgical operation) or therapy (i.e antibiotic treatment) over time;
他の名前：
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Healthy subjects
Subjects without any known ongoing disease are enrolled.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Bacterial abundances calculated by mean of Operational Taxonomic Unit (OTU) count
時間枠：Up to 24 weeks
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It is a measure of the bacterial amount
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Up to 24 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Chao's indices estimated on the total OTU amount
時間枠：Up to 24 weeks
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It is a measure of bacterial diversity
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Up to 24 weeks
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Simpson's index (D) estimated on the total OTU amount
時間枠：Up to 24 weeks
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It is a measure of bacterial diversity
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Up to 24 weeks
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Shannon's index estimated on the total OTU amount
時間枠：Up to 24 weeks
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It is a measure of bacterial diversity
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Up to 24 weeks
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The OTU abundances will be used to calculate an adjacency matrix based on the Spearman's correlation coefficient (rs) among different bacterial genus
時間枠：up to 24 weeks
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It is a measure of strength of linear association between different bacterial genera
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up to 24 weeks
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協力者と研究者
捜査官
- 主任研究者：Lorenzo Drago, Prof.、IRCCS Galeazzi Orthopedic Institute, Milan, Italy
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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