Phages Dynamics and Influences During Human Gut Microbiome Establishment (METAKIDS)

July 12, 2019 updated by: Institut Pasteur
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Essonne
      • Orsay, Essonne, France, 91400
        • Crèche du Parc
      • Orsay, Essonne, France, 91400
        • Crèche La Farandole

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 months to 9 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  1. Child attending at least 4 days a week one of the two municipal municipal nursery (crèches) in the town of Orsay (91, France);
  2. Aged less than 9 months at the time of entry to the crèche (August-October 2017);
  3. Parent (s) / legal representative not opposed to the child's participation in the research;

Exclusion Criteria:

  • Toilet training;
  • Prematurity;
  • Participation in clinical research requiring the use of a drug.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: collection of diapers with fresh stools
collection of diapers with fresh stools

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 years
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)
3 years
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
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Characterization of phages and bacteria variations in response to environmental perturbations during infant gut development
Time Frame: 2 to 3 weeks
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).
2 to 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut Pasteur

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
City of Orsay

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Martial Marbouty, Institut Pasteur / CNRS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 5, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016-097
  • ID RCB number : 2017-A00750-53 (OTHER: French national registration number of the study)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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