Influence of Intestinal Microbiota Implantation in Preterm Infants on Microbiota and Immune Orientation at 3 Years (PrimiBiota)

September 14, 2026 updated by: Centre Hospitalier Universitaire de Nīmes

Influence of Intestinal Microbiota Implantation Parameters in the Neonatal Period in Premature Infants on Microbiota Profiles and Immune Orientation at 3 Years of Age

The main objective of this research is to study the links between changes in the intestinal microbiota (in terms of diversity) during the first 6 weeks of life for preterm infants and the presence / absence of a TH1 immune status at 36 months of age.

Study Overview

Status

Status

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

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.

Detailed Description

The secondary objectives are to study the links between changes of the intestinal microbiota premature infants in terms of:

  • changing diversity of the microbiota in the first 6 weeks of life;
  • changes in the bacterial community (UniFrac study) during the first 6 weeks of life;
  • diversity of the microbiota up to 6 weeks;

-AND-

  • diversity of the microbiota at 1, 2 & 3 years;
  • bacterial communities (UniFrac study) at 1, 2 & 3 years;
  • lymphocyte subpopulation profiles at 3 years;
  • serum immunoglobulin A, G, M, E levels at 3 years;
  • history of infectious episodes, allergic and inflammatory episodes during the first 3 years of life.

The links between certain variables known in the literature and neonatal microbiota will be confirmed / studied in our population:

  • mode of delivery;
  • length (and type) of antibiotic therapy in the neonatal period;
  • duration of breastfeeding.

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.
130

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
      • Montpellier, France, 34295
        • CHRU de Montpellier - Hôpital Arnaud de Villeneuve
      • Nîmes, France, 30029
        • CHRU de Nîmes - Hôpital Universitaire Carémeau
      • Saint-Gély-du-Fesc, France, 34980
        • Réseau GRANDIR EN LANGUEDOC-ROUSILLON

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

No older than 1 day (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of premature babies born at < 33 months gestation.

Description

Inclusion Criteria:

  • The parents of the patient (or legal guardian if any) have been informed about the implementation of the study, its objectives, its constraints, and patient rights
  • The parents of the patient (or legal guardian if any) must have given their free and informed consent and signed the consent form
  • The patient must be affiliated with or beneficiary of a health insurance plan
  • Premature infants born at less than 33 weeks of gestation

Exclusion Criteria:

  • The patient is participating in another interventional study (Excepted " Recherche du Portage de Clostridium butyricum et de Toxines de Clostridium chez les Prématurés Hospitalisés en Néonatologie afin de prédire la survenue d'Entérocolites Nécrosantes", RCB 2016-A00-529-42 ; " BetaDose Dose reduction of antenatal betamethasone given to prevent the neonatal complications associated with very preterm birth ", RCB 2016-001486-90.
  • It is not possible to correctly inform the parent (or legal guardian, if applicable)
  • A serious deformity or digestive malformation was diagnosed at birth
  • During the hospital stay in the neonatology department, the patient had a digestive disease requiring surgery (except necrotizing enterocolitis)
  • A transfer to another hospital is foreseen/predictable (eg, due to geographical distance)

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.
The study population
The study population corresponds to infants born at less than 33 weeks of gestation.

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
The presence/absence of a Th1 type immune orientation
Time Frame: 36 months
Immune orientation will be determined according to the following ratio determined by lymphocyte stimulation tests: INF-gamma/(INF-gamma+IL+4). The latter ratio varies between 0 and 0.5 with IL-4 > INF-gamma (TH2 orientation) and between 0.5 and 1 when INF-gamma > IL-4 (TH1 orientation).
36 months

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
Blood lymphocyte subset determination
Time Frame: 36 months
Subsets are determined according to the presence/absence of the following differentiation clusters: CD3, CD4, CD8, CD19, CD25, CD56, CD127, FOXP3.
36 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serum Immunoglobulin A level
Time Frame: 36 months
36 months
Serum Immunoglobulin G level
Time Frame: 36 months
36 months
Serum Immunoglobulin M level
Time Frame: 36 months
36 months
Serum Immunoglobulin E level
Time Frame: 36 months
36 months
The number of days in good health and no medications
Time Frame: 36 months
36 months
Richness of fecal microbiota (number of operational taxonomic units observed)
Time Frame: Day 0 (first meconium)
Day 0 (first meconium)
Richness of fecal microbiota (number of operational taxonomic units observed)
Time Frame: Week 1
Week 1
Richness of fecal microbiota (number of operational taxonomic units observed)
Time Frame: Week 2
Week 2
Richness of fecal microbiota (number of operational taxonomic units observed)
Time Frame: Week 3
Week 3
Richness of fecal microbiota (number of operational taxonomic units observed)
Time Frame: Week 4
Week 4
Richness of fecal microbiota (number of operational taxonomic units observed)
Time Frame: Week 5
Week 5
Richness of fecal microbiota (number of operational taxonomic units observed)
Time Frame: Week 6
Week 6
Richness of fecal microbiota (number of operational taxonomic units observed)
Time Frame: 12 months
12 months
Richness of fecal microbiota (number of operational taxonomic units observed)
Time Frame: 24 months
24 months
Richness of fecal microbiota (number of operational taxonomic units observed)
Time Frame: 36 months
36 months
Diversity of fecal microbiota (Shannon's index)
Time Frame: Day 0 (first meconium)
Day 0 (first meconium)
Diversity of fecal microbiota (Shannon's index)
Time Frame: Week 1
Week 1
Diversity of fecal microbiota (Shannon's index)
Time Frame: Week 2
Week 2
Diversity of fecal microbiota (Shannon's index)
Time Frame: Week 3
Week 3
Diversity of fecal microbiota (Shannon's index)
Time Frame: Week 4
Week 4
Diversity of fecal microbiota (Shannon's index)
Time Frame: Week 5
Week 5
Diversity of fecal microbiota (Shannon's index)
Time Frame: Week 6
Week 6
Diversity of fecal microbiota (Shannon's index)
Time Frame: 12 months
12 months
Diversity of fecal microbiota (Shannon's index)
Time Frame: 24 months
24 months
Diversity of fecal microbiota (Shannon's index)
Time Frame: 36 months
36 months
Functional richness of fecal microbiota (number of functional groups observed)
Time Frame: Day 0 (first meconium)
Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.
Day 0 (first meconium)
Functional richness of fecal microbiota (number of functional groups observed)
Time Frame: Week 1
Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.
Week 1
Functional richness of fecal microbiota (number of functional groups observed)
Time Frame: Week 2
Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.
Week 2
Functional richness of fecal microbiota (number of functional groups observed)
Time Frame: Week 3
Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.
Week 3
Functional richness of fecal microbiota (number of functional groups observed)
Time Frame: Week 4
Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.
Week 4
Functional richness of fecal microbiota (number of functional groups observed)
Time Frame: Week 5
Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.
Week 5
Functional richness of fecal microbiota (number of functional groups observed)
Time Frame: Week 6
Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.
Week 6
Functional richness of fecal microbiota (number of functional groups observed)
Time Frame: 12 months
Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.
12 months
Functional richness of fecal microbiota (number of functional groups observed)
Time Frame: 24 months
Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.
24 months
Functional richness of fecal microbiota (number of functional groups observed)
Time Frame: 36 months
Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.
36 months
Functional diversity of fecal microbiota (Shannon's index)
Time Frame: Day 0 (first meconium)
Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.
Day 0 (first meconium)
Functional diversity of fecal microbiota (Shannon's index)
Time Frame: Week 1
Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.
Week 1
Functional diversity of fecal microbiota (Shannon's index)
Time Frame: Week 2
Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.
Week 2
Functional diversity of fecal microbiota (Shannon's index)
Time Frame: Week 3
Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.
Week 3
Functional diversity of fecal microbiota (Shannon's index)
Time Frame: Week 4
Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.
Week 4
Functional diversity of fecal microbiota (Shannon's index)
Time Frame: Week 5
Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.
Week 5
Functional diversity of fecal microbiota (Shannon's index)
Time Frame: Week 6
Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.
Week 6
Functional diversity of fecal microbiota (Shannon's index)
Time Frame: 12 months
Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.
12 months
Functional diversity of fecal microbiota (Shannon's index)
Time Frame: 24 months
Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.
24 months
Functional diversity of fecal microbiota (Shannon's index)
Time Frame: 36 months
Functional groups are determined via the classification of each OTU according to the following factors: 1) pathogenicity (pathogen/intermediate/commensal); 2) aerobic versus anaerobic; 3) Cocci + versus others.
36 months
The relative abundance of primary fecal microbiota families
Time Frame: Day 0 (first meconium)
Day 0 (first meconium)
The relative abundance of primary fecal microbiota families
Time Frame: Week 1
Week 1
The relative abundance of primary fecal microbiota families
Time Frame: Week 2
Week 2
The relative abundance of primary fecal microbiota families
Time Frame: Week 3
Week 3
The relative abundance of primary fecal microbiota families
Time Frame: Week 4
Week 4
The relative abundance of primary fecal microbiota families
Time Frame: Week 5
Week 5
The relative abundance of primary fecal microbiota families
Time Frame: Week 6
Week 6
The relative abundance of primary fecal microbiota families
Time Frame: 12 months
12 months
The relative abundance of primary fecal microbiota families
Time Frame: 24 months
24 months
The relative abundance of primary fecal microbiota families
Time Frame: 36 months
36 months
Fecal microbiota unifrac ordination score
Time Frame: Day 0 (first meconium)
Day 0 (first meconium)
Fecal microbiota unifrac ordination score
Time Frame: Week 1
Week 1
Fecal microbiota unifrac ordination score
Time Frame: Week 2
Week 2
Fecal microbiota unifrac ordination score
Time Frame: Week 3
Week 3
Fecal microbiota unifrac ordination score
Time Frame: Week 4
Week 4
Fecal microbiota unifrac ordination score
Time Frame: Week 5
Week 5
Fecal microbiota unifrac ordination score
Time Frame: Week 6
Week 6
Fecal microbiota unifrac ordination score
Time Frame: 12 months
12 months
Fecal microbiota unifrac ordination score
Time Frame: 24 months
24 months
Fecal microbiota unifrac ordination score
Time Frame: 36 months
36 months

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.
Centre Hospitalier Universitaire de Nīmes

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: Anne Filleron, MD, PhD, Centre Hospitalier Universitaire de Nîmes

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.
May 12, 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.
November 28, 2022

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.
June 1, 2026

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).
April 11, 2016

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.
April 13, 2016

First Posted (Estimated)

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.
April 14, 2016

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.
September 16, 2026

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.
September 14, 2026

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.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • PHRC-I/2015/AF-01

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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