COMBINE Infant Formula Study

The Infant Formula Study is a nested dietary intervention study in the COMBINE Cohort Study

This study will explore whether the MFGM protein, found naturally in breastmilk, could benefit formula-fed babies. Recent research has suggested that this protein is important for healthy brain development and formula products that are currently available do not contain this protein. This trial will assess whether adding the protein improves the nutritional content of infant formula.

 

What is the MFGM protein?


The babies enrolled on the trial will be part of a randomised control study trial (the gold standard for clinical trial research). They will be provided with either standard formula or the same formula with added MFGM protein. The formula will be provided free of charge to the families participating. We provide the formula to the families participating in order to record all batch numbers and maintain traceability. Both formulas meet all CODEX and EFSA European safety standards. This trial has full ethical approval and all families participating give informed consent.


Both the INFANT Research Centre and CUMH advocate breastfeeding at all times: we know breast is best. Nevertheless, for a variety of reasons, some mothers cannot, or choose not to, breastfeed. We firmly believe that babies who receive formula should receive the best possible product, and research such as this is very important.


The COMBINE Infant Formula Study is ONLY open to mothers who already exclusively formula feed their babies. The babies will have all the COMBINE check-ups for the 12 months they are using the formula and the following year. If, for any reason, mothers decide they no longer wish to continue with the formula study, they can withdraw at any time without it affecting their participation in the COMBINE Cohort Study.


The results of the infant formula will be made publicly available. We hope that this research will lead to policy change and the enhancement of all infant formula, regardless of the brand.

If you would like any further information, please contact the team on combine@ucc.ie

For more information on Clinical Trials, click here
For more information on infant formula safety standards, click here

 

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