Human Gut Microbiome DevelopmentMETAKIDSNCT03296631
Phages Dynamics and Influences During Human Gut Microbiome Establishment
An observational study of Human Gut Microbiome Development, run by Institut Pasteur at 2 sites in France.
Trial summary
Microbial communities are key components of human environment. Consequently, human gut microbiome have been extensively studied providing a better understanding of the relations between bacterial populations and host physiology. Read more about this study
- Who is it for?
- Ages 10 weeks to 9 monthsHealthy volunteers can take part
- Conditions the study is for
- Human Gut Microbiome Development
- What is being tested?
- collection of diapers with fresh stools
- How many people
- 19 participants
- Where
- 2 sitesFrance
- Study dates
- 5 Sep 2017to 31 Dec 2018
- 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 10 weeks to 9 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children being in age to attend in a nursery day care structure of the town of Orsay (France) and aged less than 9 months.
Who may be able to join
- Child attending at least 4 days a week one of the two municipal municipal nursery (crèches) in the town of Orsay (91, France);
- Aged less than 9 months at the time of entry to the crèche (August-October 2017);
- Parent (s) / legal representative not opposed to the child's participation in the research;
Who cannot join
- Toilet training;
- Prematurity;
- Participation in clinical research requiring the use of a drug.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Crèche du Parc
Orsay, Essonne, 91400
Crèche La Farandole
Orsay, Essonne, 91400
About this study
Microbial communities are key components of human environment. Consequently, human gut microbiome have been extensively studied providing a better understanding of the relations between bacterial populations and host physiology. However, a typical analysis tends to elude the complexity of the mixes in term of species, strains, as well as extra-chromosomal DNA molecules such as and phages. MetaKids project aims at bringing, at an unprecedented resolution, a new view of those populations and the internal relationships during human gut establishment, a crucial step with long-term impacts on host health. This project relies on the ability of Meta3C, a newly technique developed in the lab, to identify the bacterial host genomes of the different phages the investigators will detect thanks to the physical collision these molecules experience. Given the role that human gut phages may play in shaping the development of host microbiomes, their potential for application is of great interest.
Read the detailed description
Over the last decade, the role of microorganisms residing in human intestines has been intensively studied. The intestinal microbiome includes bacteria, viruses, fungi and archaea. The importance of microbiome to human health is highlighted by the observation that dysbiotic shifts in these microbial communities have been associated with numerous human diseases, including obesity, inflammatory bowel disorders, autoimmune disease or gastrointestinal cancer. It is also clearly established that some of these microorganisms interact with the immune system and contribute to its development. The intestinal microbiome is established soon after birth, and its composition changes over the next several years toward a stereotypical 'adult-like' bacterial community structure. Epidemiological studies have demonstrated the importance of this period for a long-term health. It also has been shown that this process can be influenced by multiple interacting factors such as nutrition, antibiotic use and others environmental factors. Much less is known on the viral part of human microbiome. Most of them are phages (phageome) that are known to modulate microbial population through predation or transfer of genetic information between bacteria, and are likely to have important effects on intestinal microbiome establishment and, consequently, human physiology. MetaKids project aims at understanding how the gut phageome develops during the early human life and how it influences the composition of the bacterial microbiome. The investigators will carry a longitudinal study of 15-20 infants from 3-9 months till age 24-30 months. By combining latest metagenomic methods, will be investigated: 1) the composition, evolution and dynamic of the phageome and bacterial microbiome over this critical period; 2) the interactions between phages and bacteria and their relationships; and 3) the impact of environmental factors, like vaccinations or antibiotics treatment on the phages populations. The project is based on the combination of innovative recent metagenomic techniques developed in the lab. DNA is an ubiquitous and stable molecule that can be used as a marker of "compartmentalization" at cellular and population levels, providing important information regarding the genomic structure of a mix of species. Therefore, by combining approaches like purification of virales particles and 3C related methods, the investigators propose to characterize infant gut microbiome establishment and decipher the relationships between the different genomic entities present during this period. This project will bring crucial data on the role of phages during early life of human intestinal tract. Intervention to modify/control intestinal population is a dynamic field and MetaKids project will bring new perspectives for this research area.
- Conditions
- Human Gut Microbiome Development
- Being tested
- collection of diapers with fresh stools
- Keywords
- microbiome, gut, infant gut, phages, phages-bacteria interactions, microbiome development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of diapers with fresh stoolsOther
collection of diapers with fresh stools
| Study group | Role | What they receive |
|---|---|---|
| children | Enrollment of 15 to 20 children (< 9 months old) at the early beginning of their entry in nursery (crèche) between August and November 2017.
This cohort will be followed during a maximum period of 36 months . Diapers with fresh stools will be collected once a week per child and then frozen.
Spontaneous personal day care informations given by the parents to the nurses and recorded in each child's daily logbook will be collected for the research. No specific interviews will be conducted. Receives: Other: collection of diapers with fresh stools |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of phages and bacteria genomes during infant gut development.
Genomic reconstruction and characterization of the different genomes (phages, bacteria, yeast) present in the human gut during the three first years of life. This outcomes will provide a large catalog of DNA sequences.
Measured: 3 years
Characterization of phages and bacteria abundance and variations during infant gut development
Characterization of the variation of the different species present in human gut during the 3 first years of life. This outcomes will provide access to the dynamics of the different species present during this period and possibility to correlate them with environmental variation (dietary, age)
Measured: 3 years
Characterization of phages-bacteria interactions
Phages are the major predator of bacteria but their role during human gut establishment remains poorly characterized. This catalog of interactions will allow to understand the role of the phages during human gut development
Measured: 3 years
Secondary outcomes (1)
Characterization of phages and bacteria variations in response to environmental perturbations during infant gut development
Characterization of the small variations of the different species present in human gut during the 3 first years of life in response to environmental perturbations. This outcome will provide access to the dynamics of the different species present during this period and possibility to correlate them with environmental perturbations (antibiotic, vaccine, illness).
Measured: 2 to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start5 Sep 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Why it stopped: The Pi has estimated that he has received sufficiently biological samples and associated data. it's no longer worth following up.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Gut Microbiome DevelopmentStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- City of Orsay
- Responsible party
- Sponsor
- Investigators
- Martial Marbouty, Study director, Institut Pasteur / CNRS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03296631
- Sponsor's protocol ID
- 2016-097
- Other IDs
- ID RCB number : 2017-A00750-53
- Acronym
- METAKIDS
- Status last verified
- Jul 2019
- First submitted
- 1 Aug 2017
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phages Dynamics and Influences During Human Gut Microbiome Establishment
- ClinicalTrials.gov ID
- NCT03296631
- Acronym / sponsor ID
- METAKIDS / 2016-097
- Conditions
- Human Gut Microbiome Development
- Keywords
- microbiome, gut, infant gut, phages, phages-bacteria interactions, microbiome development
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The Pi has estimated that he has received sufficiently biological samples and associated data. it's no longer worth following up.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- City of Orsay
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 28 Sep 2017 (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.
Microbial communities are key components of human environment. Consequently, human gut microbiome have been extensively studied providing a better understanding of the relations between bacterial populations and host physiology. However, a typical analysis tends to elude the complexity of the mixes in term of species, strains, as well as extra-chromosomal DNA molecules such as and phages. MetaKids project aims at bringing, at an unprecedented resolution, a new view of those populations and the internal relationships during human gut establishment, a crucial step with long-term impacts on host health. This project relies on the ability of Meta3C, a newly technique developed in the lab, to identify the bacterial host genomes of the different phages the investigators will detect thanks to the physical collision these molecules experience. Given the role that human gut phages may play in shaping the development of host microbiomes, their potential for application is of great interest.
Detailed description
Over the last decade, the role of microorganisms residing in human intestines has been intensively studied. The intestinal microbiome includes bacteria, viruses, fungi and archaea. The importance of microbiome to human health is highlighted by the observation that dysbiotic shifts in these microbial communities have been associated with numerous human diseases, including obesity, inflammatory bowel disorders, autoimmune disease or gastrointestinal cancer. It is also clearly established that some of these microorganisms interact with the immune system and contribute to its development. The intestinal microbiome is established soon after birth, and its composition changes over the next several years toward a stereotypical 'adult-like' bacterial community structure. Epidemiological studies have demonstrated the importance of this period for a long-term health. It also has been shown that this process can be influenced by multiple interacting factors such as nutrition, antibiotic use and others environmental factors. Much less is known on the viral part of human microbiome. Most of them are phages (phageome) that are known to modulate microbial population through predation or transfer of genetic information between bacteria, and are likely to have important effects on intestinal microbiome establishment and, consequently, human physiology. MetaKids project aims at understanding how the gut phageome develops during the early human life and how it influences the composition of the bacterial microbiome. The investigators will carry a longitudinal study of 15-20 infants from 3-9 months till age 24-30 months. By combining latest metagenomic methods, will be investigated: 1) the composition, evolution and dynamic of the phageome and bacterial microbiome over this critical period; 2) the interactions between phages and bacteria and their relationships; and 3) the impact of environmental factors, like vaccinations or antibiotics treatment on the phages populations. The project is based on the combination of innovative recent metagenomic techniques developed in the lab. DNA is an ubiquitous and stable molecule that can be used as a marker of "compartmentalization" at cellular and population levels, providing important information regarding the genomic structure of a mix of species. Therefore, by combining approaches like purification of virales particles and 3C related methods, the investigators propose to characterize infant gut microbiome establishment and decipher the relationships between the different genomic entities present during this period. This project will bring crucial data on the role of phages during early life of human intestinal tract. Intervention to modify/control intestinal population is a dynamic field and MetaKids project will bring new perspectives for this research area.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children | – | Other: collection of diapers with fresh stoolsEnrollment of 15 to 20 children (< 9 months old) at the early beginning of their entry in nursery (crèche) between August and November 2017. This cohort will be followed during a maximum period of 36 months . Diapers with fresh stools will be collected once a week per child and then frozen. Spontaneous personal day care informations given by the parents to the nurses and recorded in each child's daily logbook will be collected for the research. No specific interviews will be conducted. |
Who may qualify
- Ages
- 10 weeks to 9 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children being in age to attend in a nursery day care structure of the town of Orsay (France) and aged less than 9 months.
Key inclusion criteria (3 listed)
- Child attending at least 4 days a week one of the two municipal municipal nursery (crèches) in the town of Orsay (91, France);
- Aged less than 9 months at the time of entry to the crèche (August-October 2017);
- Parent (s) / legal representative not opposed to the child's participation in the research;
Key exclusion criteria (3 listed)
- Toilet training;
- Prematurity;
- Participation in clinical research requiring the use of a drug.
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 |
|---|---|---|
| collection of diapers with fresh stoolscollection of diapers with fresh stools | Other | children |
Primary outcome
Characterization of phages and bacteria genomes during infant gut development.
Time frame: 3 years
Genomic reconstruction and characterization of the different genomes (phages, bacteria, yeast) present in the human gut during the three first years of life. This outcomes will provide a large catalog of DNA sequences.
Characterization of phages and bacteria abundance and variations during infant gut development
Time frame: 3 years
Characterization of the variation of the different species present in human gut during the 3 first years of life. This outcomes will provide access to the dynamics of the different species present during this period and possibility to correlate them with environmental variation (dietary, age)
Characterization of phages-bacteria interactions
Time frame: 3 years
Phages are the major predator of bacteria but their role during human gut establishment remains poorly characterized. This catalog of interactions will allow to understand the role of the phages during human gut development
1 secondary outcome
Characterization of phages and bacteria variations in response to environmental perturbations during infant gut development
Time frame: 2 to 3 weeks
Results and safety
The study was stopped early (reason given: The Pi has estimated that he has received sufficiently biological samples and associated data. it's no longer worth following up.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Martial Marbouty study director
Institut Pasteur / CNRS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Gut Microbiome Development, run by Institut Pasteur at 2 sites in France.
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 3 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: stopped early, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
The study was stopped early (reason given: The Pi has estimated that he has received sufficiently biological samples and associated data. it's no longer worth following up.). 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?
Characterization of phages and bacteria genomes during infant gut development. (time frame: 3 years). The study lists 3 primary outcomes in all. 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 Jul 2019.