An observational study in Healthy Newborn Infants, sponsored by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement. Recruiting at 1 site in France. Open to participants aged 2 Days to 4 Days. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement · Observational
The bacteria and other microorganisms that naturally live in the gut (the gut microbiome) play an important role in a baby's early development. Babies born by cesarean section are exposed to different microorganisms at birth than babies born vaginally, which may affect the normal establishment of the gut microbiome.Early changes in the gut microbiome can affect the development and function of the immune system, as well as metabolism and gut function, and may increase the risk of certain diseases later in life. They have also been associated with infant colic, a common condition that may be related to increased sensitivity to abdominal pain.
Current approaches to restore the gut microbiome after cesarean birth, such as transferring the mother's vaginal or fecal microbiota, raise important safety concerns. This study aims to better understand how differences in the early gut microbiome influence gut development, immune function, and pain sensitivity, and to identify naturally occurring beneficial bacteria that could provide a safer alternative.
To achieve this, the researchers will study stool samples from newborns delivered vaginally or by cesarean section. Gut bacteria will be isolated and characterized in the laboratory, and selected microorganisms will be evaluated in preclinical models to better understand their effects on gut and immune development. The findings may support the development of new probiotic approaches to promote healthy gut microbiome development in infants born by cesarean section and reduce the long-term health consequences of early microbiome disruption.
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement is the lead sponsor of 50 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Babies born vaginally or by cesarean section (2 to 4 days old)
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Exclusion Criteria of the babies :
Measure of colorectal distension in a germ-free mouse model colonized with an altered early human microbiota
Time frame: up to 4 years
Other open studies at Hopital Paris-Saclay (GHNE), Orsay
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Plan to share: Undecided
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Started Oct 2026 (actual). Primary completion is estimated for Oct 2030, 48 months after the start.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement