Trial Information

Summary: Infant Formula Research

This study will test babies taking an experimental infant formula, babies taking an infant formula already being sold in stores, and babies taking their mother's breast milk to evaluate how they effect babies' bowel movements.

Your baby may qualify to participate in this study if he or she:

• Is only taking regular infant formula like you buy at the store or is only taking breast milk.
• Is healthy and growing right for his or her age
• Was born after at least 37 weeks of gestation
• Is younger than 30 days old when you talk to your doctor

This nutrient formula content meets FDA requirements for infant formula, but there is a small amount of risk that your baby will not grow well while taking this formula. This is why coming to all of your baby's scheduled visits is important so your doctor can watch how your baby is growing.

If you are interested in your baby being part of this study and if he or she qualifies, there are certain things you will be asked to do that are related to the study.

These include:

• Making 4 visits to your doctor's office during the next 3 months
• Giving your written permission on an informed consent form for your baby to be in the study
• Giving your written permission for your baby's study related medical records to be reviewed by people from the formula company
• Giving your written permission for your medical records to be reviewed by people from the formula company
• Letting the research staff measure your baby's weight, at each visit, and length, and head size at two visits
• Answering questions about your baby's sleep
• Answering questions about how your baby is doing on the formula
• Answering questions about the formula itself
• Feeding your baby the formula you are assigned by the research staff or feeding breast milk
• Collecting three samples of your babies bowel movements 3 different times in a two month period.

You will get formula to feed your baby (or gift cards in the amount of the formula if you are breastfeeding) the whole time he or she continues in the study for up to 3 months of age. You will also get reimbursement for time and travel and receive 2 cases of formula (approximately a 2 month supply) or two gift cards (if you are breastfeeding) for completing study tasks.

If you want to see if your baby can be in this study, please let your doctor know.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.