In this study, betaine intake will be increased in formula-fed infants through formula milk supplementation. To do this, a double-blind randomized study has been designed with the supplementation group (infant formula supplemented with betaine) and control group (unsupplemented infant formula). The main objectives of the study are to determine the safety of supplementation and to assess whether there are changes in infant growth.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Change in weight-for-length z score
Timeframe: From start to the end of treatment at 12 weeks and at 12 months of follow-up
Changes in fecal microbiota composition
Timeframe: At 4 weeks and 12 weeks end of treatment, and at 12 months of follow-up