Infant, PrematurePrimiBiotaNCT02738411
Influence of Intestinal Microbiota Implantation in Preterm Infants on Microbiota and Immune Orientation at 3 Years
An observational study of Infant, Premature, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 1 day
- Conditions the study is for
- Infant, Premature
- How many people
- 130 participants
- Where
- 3 sitesFrance
- Study dates
- 12 May 2017to 1 Jun 2026
- 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 Up to 1 day
- All sexes
- No healthy volunteers
- Child
Study population: The study population consists of premature babies born at < 33 months gestation.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHRU de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, 34295
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
Réseau GRANDIR EN LANGUEDOC-ROUSILLON
Saint-Gély-du-Fesc, 34980
About this study
Official title: 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.
Read the 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.
- Conditions
- Infant, Premature
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| The study population | The study population corresponds to infants born at less than 33 weeks of gestation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence/absence of a Th1 type immune orientation
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).
Measured: 36 months
Secondary outcomes (1)
Blood lymphocyte subset determination
Subsets are determined according to the presence/absence of the following differentiation clusters: CD3, CD4, CD8, CD19, CD25, CD56, CD127, FOXP3.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study start12 May 2017
- Primary completion28 Nov 2022
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, PrematureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Filleron, MD, PhD, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02738411
- Sponsor's protocol ID
- PHRC-I/2015/AF-01
- Acronym
- PrimiBiota
- Status last verified
- Sep 2026
- First submitted
- 11 Apr 2016
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Intestinal Microbiota Implantation Parameters in the Neonatal Period in Premature Infants on Microbiota Profiles and Immune Orientation at 3 Years of Age
- ClinicalTrials.gov ID
- NCT02738411
- Acronym / sponsor ID
- PrimiBiota / PHRC-I/2015/AF-01
- Conditions
- Infant, Premature
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 12 May 2017 (actual)
- Primary completion
- 28 Nov 2022 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 14 Apr 2016 (estimated)
- 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 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study population | – | –The study population corresponds to infants born at less than 33 weeks of gestation. |
Who may qualify
- Ages
- Up to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population consists of premature babies born at < 33 months gestation.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
1 secondary outcome
Blood lymphocyte subset determination
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
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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.
Anne Filleron, MD, PhD study director
Centre Hospitalier Universitaire de Nīmes
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, Premature, run by Centre Hospitalier Universitaire de Nīmes at 3 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The presence/absence of a Th1 type immune orientation (time frame: 36 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 2026.