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

NCT ID: NCT02738411

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 130 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-12
• Study Completion Date: 2025-12-30

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

The study population

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

No interventions assigned to this group

Eligibility Criteria

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)

• Maximum Eligible Age: 1 Day
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne Filleron, MD, PhD

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Nîmes

Locations

CHRU de Montpellier - Hôpital Arnaud de Villeneuve

Montpellier, , France

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Réseau GRANDIR EN LANGUEDOC-ROUSILLON

Saint-Gély-du-Fesc, , France

Countries

France

Other Identifiers

PHRC-I/2015/AF-01

Identifier Type: -

Identifier Source: org_study_id