NCT02738411

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 130 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 1 Day
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2017-05-12
• Primary completion: 2022-11-28
• Completion: 2025-12-30
• First posted: 2016-04-14
• Last updated: 2025-11-17

Locations

3 sites across 1 country: France