DiseaseqMHDNCT03388424
Quantification of Microbiota in Health and Diseases
An observational study of Disease, run by University of Catanzaro at 1 site in Italy.
Trial summary
Microbiota consists of trillions of microorganisms located in all the biological cavity. The relationships between individual health status and microbiota are based on a sort of "mutual cooperation." The balance of the microbiota can be compromised by various factors such as environmental, psycho-physical stress… Read more about this study
- Who is it for?
- Ages 4 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Disease
- What is being tested?
- quantification of microbiota
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 22 Nov 2017to 21 Nov 2022
- 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 4 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Health and disease patients, after a detailed history will be enrolled in one of the six groups and a biological sample will be take for the examination using the n-counter platform.
Who may be able to join
- all patients will be enclosed in each group in agreement with the characteristics of the groups
Who cannot join
- Patients who will not sign the informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
AO Materdomini
Catanzaro, Italia, 88100
Luca Gallelli, MD, +390961712537, gallelli@unicz.it
About this study
Microbiota consists of trillions of microorganisms located in all the biological cavity. The relationships between individual health status and microbiota are based on a sort of "mutual cooperation." The balance of the microbiota can be compromised by various factors such as environmental, psycho-physical stress, malnutrition (over or low), breastfeeding, chronic diseases, oncology and pharmacological treatments (especially antibiotics and chemotherapics). The impact of dysbiosis on today's society affects over 70% of the world population
Read the detailed description
Intestinal microbiota is defined as the strongest modulator of the human genome and it is considered the "second brain" of our organism for its bi-directional communication with the central nervous system. Microbiota consists of trillions of microorganisms located in all the biological cavity, In the intestine it is distributed in ecological niches having multiple metabolic activities which influence individual health. Microbiota acts as barrier against pathogens, regulating the absorption of nutrients, the production of energy and the development of the immune system4. Intestinal bacteria are generally divided into 4 Phylum: Firmicutes, Actinobacteria, Proteobacteria and Bacteriodetes, in which their proportion shows a correlation with individuals health status. When in equilibrium among them, these bacteria are essential for the good health of the digestive tract, the good function of immune system and for brain performace. The relationships between individual health status and microbiota are based on a sort of "mutual cooperation." The balance of the microbiota can be compromised by various factors such as environmental, psycho-physical stress, malnutrition (over or low), breastfeeding, chronic diseases, oncology and pharmacological treatments (especially antibiotics and chemotherapics). This disequilibrium leads to altered capability of bacteria to properly extract calories from food affecting the trend of many pathophisilogical status such as obesity, allergic states, inflammatory bowel syndromes cardiovascular diseases, metabolic, oncological and neurodegenerative diseases. The impact of dysbiosis on today's society affects over 70% of the world population
- Conditions
- Disease
- Being tested
- quantification of microbiota
- Keywords
- bacterial DNA, RNA16S gene
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quantification of microbiotaDiagnostic test
For each group a sample of biological sample will be take and will be analyzed using the n-counter flex platform in order to quantify disbiosis
| Study group | Role | What they receive |
|---|---|---|
| Control | Healthy people of both sex Receives: Diagnostic Test: quantification of microbiota | |
| quantification of microbiota in Brain | Patients of both sex with neural disorders and diseases Receives: Diagnostic Test: quantification of microbiota | |
| quantification of microbiota in GI | Patients of both sex with gastrointestinal diseases Receives: Diagnostic Test: quantification of microbiota | |
| quantification of microbiota in Lung | Patients of both sex with Respiratory diseases Receives: Diagnostic Test: quantification of microbiota | |
| quantification of microbiota Metabolic | Patients of both sex with Metabolic Diseases Receives: Diagnostic Test: quantification of microbiota | |
| quantification of microbiota in UG | Patients of both sex with Uro-genital Diseases Receives: Diagnostic Test: quantification of microbiota |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of microbiota percentage
we will determine the difference of microbiota percentage in diseases-groups respect to control-group
Measured: 12 months
Secondary outcomes (1)
Determination of antibiotic resistance gene
it will be evaluate the presence of antibiotic resistance gene in diseases-group respect to control-group
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start22 Nov 2017
- Primary completion21 May 2020
- Study completion21 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiseaseStudies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Catanzaro
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Sanitaria Provinciale Di Catanzaro
- Responsible party
- Principal investigator, Luca Gallelli, University of Catanzaro
- Investigators
- Luca Gallelli, MD, Principal investigator, University of Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388424
- Sponsor's protocol ID
- Microbiota2018
- Acronym
- qMHD
- Status last verified
- Sep 2020
- First submitted
- 22 Dec 2017
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data will kept in hospital and results will be published
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Microbiota in Health and Diseases
- ClinicalTrials.gov ID
- NCT03388424
- Acronym / sponsor ID
- qMHD / Microbiota2018
- Conditions
- Disease
- Keywords
- bacterial DNA, RNA16S gene
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of CatanzaroUniversity, hospital or other
- Collaborators
- Azienda Sanitaria Provinciale Di Catanzaro
- Study start
- 22 Nov 2017 (actual)
- Primary completion
- 21 May 2020 (actual)
- Study completion
- 21 Nov 2022 (estimated)
- First posted
- 3 Jan 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.
Microbiota consists of trillions of microorganisms located in all the biological cavity. The relationships between individual health status and microbiota are based on a sort of "mutual cooperation." The balance of the microbiota can be compromised by various factors such as environmental, psycho-physical stress, malnutrition (over or low), breastfeeding, chronic diseases, oncology and pharmacological treatments (especially antibiotics and chemotherapics). The impact of dysbiosis on today's society affects over 70% of the world population
Detailed description
Intestinal microbiota is defined as the strongest modulator of the human genome and it is considered the "second brain" of our organism for its bi-directional communication with the central nervous system. Microbiota consists of trillions of microorganisms located in all the biological cavity, In the intestine it is distributed in ecological niches having multiple metabolic activities which influence individual health. Microbiota acts as barrier against pathogens, regulating the absorption of nutrients, the production of energy and the development of the immune system4. Intestinal bacteria are generally divided into 4 Phylum: Firmicutes, Actinobacteria, Proteobacteria and Bacteriodetes, in which their proportion shows a correlation with individuals health status. When in equilibrium among them, these bacteria are essential for the good health of the digestive tract, the good function of immune system and for brain performace. The relationships between individual health status and microbiota are based on a sort of "mutual cooperation." The balance of the microbiota can be compromised by various factors such as environmental, psycho-physical stress, malnutrition (over or low), breastfeeding, chronic diseases, oncology and pharmacological treatments (especially antibiotics and chemotherapics). This disequilibrium leads to altered capability of bacteria to properly extract calories from food affecting the trend of many pathophisilogical status such as obesity, allergic states, inflammatory bowel syndromes cardiovascular diseases, metabolic, oncological and neurodegenerative diseases. The impact of dysbiosis on today's society affects over 70% of the world population
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Control | – | Diagnostic Test: quantification of microbiotaHealthy people of both sex |
| quantification of microbiota in Brain | – | Diagnostic Test: quantification of microbiotaPatients of both sex with neural disorders and diseases |
| quantification of microbiota in GI | – | Diagnostic Test: quantification of microbiotaPatients of both sex with gastrointestinal diseases |
| quantification of microbiota in Lung | – | Diagnostic Test: quantification of microbiotaPatients of both sex with Respiratory diseases |
| quantification of microbiota Metabolic | – | Diagnostic Test: quantification of microbiotaPatients of both sex with Metabolic Diseases |
| quantification of microbiota in UG | – | Diagnostic Test: quantification of microbiotaPatients of both sex with Uro-genital Diseases |
Who may qualify
- Ages
- 4 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Health and disease patients, after a detailed history will be enrolled in one of the six groups and a biological sample will be take for the examination using the n-counter platform.
Key inclusion criteria (1 listed)
- all patients will be enclosed in each group in agreement with the characteristics of the groups
Key exclusion criteria (1 listed)
- Patients who will not sign the informed consent
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 |
|---|---|---|
| quantification of microbiotaFor each group a sample of biological sample will be take and will be analyzed using the n-counter flex platform in order to quantify disbiosis | Diagnostic test | Control, quantification of microbiota Metabolic, quantification of microbiota in Brain, quantification of microbiota in GI, quantification of microbiota in Lung, quantification of microbiota in UG |
Primary outcome
Determination of microbiota percentage
Time frame: 12 months
we will determine the difference of microbiota percentage in diseases-groups respect to control-group
1 secondary outcome
Determination of antibiotic resistance gene
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Individual participant dataSharing planned: No. data will kept in hospital and results will be published
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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.
Luca Gallelli, MD principal investigator
University of Catanzaro
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 Disease, run by University of Catanzaro 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 1 inclusion and 1 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 16 Sep 2020. 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?
Contact Luca Gallelli, MD (+390961712322, gallelli@unicz.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of microbiota percentage (time frame: 12 months). 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 16 Sep 2020.