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
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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MI
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Milan, MI, 이탈리아, 20161
- IRCCS Istituto Ortopedico Galeazzi
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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
설명
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;
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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;
다른 이름들:
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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;
다른 이름들:
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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;
다른 이름들:
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Healthy subjects
Subjects without any known ongoing disease are enrolled.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Bacterial abundances calculated by mean of Operational Taxonomic Unit (OTU) count
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Chao's indices estimated on the total OTU amount
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Lorenzo Drago, Prof., IRCCS Galeazzi Orthopedic Institute, Milan, Italy
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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