Microbial ColonizationMicroSPNCT03460392
Study of Human Microbiota in Healthy and Pathological Conditions
An observational study of Microbial Colonization, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization
- What is being tested?
- Antibiotic therapy
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 12 Jun 2017to 31 Dec 2019
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Microbial Colonization
- Being tested
- Antibiotic therapy
- Keywords
- Human microbiota
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic therapyDrug
Also called Probiotics, dietary factors, cosmetics and adjuvants
To evaluate the effects of a specific event (i.e. surgical operation) or therapy (i.e antibiotic treatment) over time;
| Study group | Role | What they receive |
|---|---|---|
| Neurological and behavioral disorders | Subjects with neurological or behavioral disorders such as Tourette syndrome are enrolled. Receives: Drug: Antibiotic therapy | |
| Subjects affected by bone diseases | Subjects affected by bone diseases such as infective osteomyelitis or osteoporosis are enrolled. Receives: Drug: Antibiotic therapy | |
| 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. Receives: Drug: Antibiotic therapy | |
| Healthy subjects | Subjects without any known ongoing disease are enrolled. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial abundances calculated by mean of Operational Taxonomic Unit (OTU) count
It is a measure of the bacterial amount
Measured: Up to 24 weeks
Secondary outcomes (4)
Chao's indices estimated on the total OTU amount
It is a measure of bacterial diversity
Measured: Up to 24 weeks
Simpson's index (D) estimated on the total OTU amount
It is a measure of bacterial diversity
Measured: Up to 24 weeks
Shannon's index estimated on the total OTU amount
It is a measure of bacterial diversity
Measured: 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
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start12 Jun 2017
- Primary completion31 Jul 2017
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lorenzo Drago, Prof., Principal investigator, IRCCS Galeazzi Orthopedic Institute, Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460392
- Sponsor's protocol ID
- MiscoSP
- Acronym
- MicroSP
- Status last verified
- Feb 2018
- First submitted
- 15 Feb 2018
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Human Microbiota in Healthy and Pathological Conditions
- ClinicalTrials.gov ID
- NCT03460392
- Acronym / sponsor ID
- MicroSP / MiscoSP
- Conditions
- Microbial Colonization
- Keywords
- Human microbiota
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 9 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Neurological and behavioral disorders | – | Drug: Antibiotic therapySubjects with neurological or behavioral disorders such as Tourette syndrome are enrolled. |
| Subjects affected by bone diseases | – | Drug: Antibiotic therapySubjects affected by bone diseases such as infective osteomyelitis or osteoporosis are enrolled. |
| 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 | – | Drug: Antibiotic therapyPatients subjected to prolonged antibiotic therapies and undergone a variety of surgical procedures are enrolled. |
| Healthy subjects | – | –Subjects without any known ongoing disease are enrolled. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibiotic therapyAlso: Probiotics, dietary factors, cosmetics and adjuvantsTo evaluate the effects of a specific event (i.e. surgical operation) or therapy (i.e antibiotic treatment) over time; | Drug | Neurological and behavioral disorders, Prolonged antibiotic therapy, Subjects affected by bone diseases |
Primary outcome
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
4 secondary outcomes
Chao's indices estimated on the total OTU amount
Time frame: Up to 24 weeks
Simpson's index (D) estimated on the total OTU amount
Time frame: Up to 24 weeks
Shannon's index estimated on the total OTU amount
Time frame: 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
Time frame: up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorenzo Drago, Prof. principal investigator
IRCCS Galeazzi Orthopedic Institute, Milan, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microbial Colonization, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial abundances calculated by mean of Operational Taxonomic Unit (OTU) count (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2018.