Influence of Intestinal Microbiota Implantation in Preterm Infants on Microbiota and Immune Orientation at 3 Years
- Conditions
- Infant, Premature
- Registration Number
- NCT02738411
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 130
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The presence/absence of a Th1 type immune orientation 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).
- Secondary Outcome Measures
Name Time Method Blood lymphocyte subset determination 36 months Subsets are determined according to the presence/absence of the following differentiation clusters: CD3, CD4, CD8, CD19, CD25, CD56, CD127, FOXP3.
Trial Locations
- Locations (3)
CHRU de Montpellier - Hôpital Arnaud de Villeneuve
🇫🇷Montpellier, France
CHRU de Nîmes - Hôpital Universitaire Carémeau
🇫🇷Nîmes Cedex 09, France
Réseau GRANDIR EN LANGUEDOC-ROUSILLON
🇫🇷Saint Gely Du Fesc, France