A Study for Formula Fed and Breastfed Healthy Infants

Why are we doing this research?

Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to compare the growth and tolerance of an infant formula containing a new ingredient (human milk oligosaccharide or HMO) to a standard infant formula. A group of exclusively breastfed infants will also be included.

Who can participate?

Healthy infants less than 30 days old who are exclusively formula fed or breastfed may be eligible to participate.

Conditions

  • Healthy Babies Children and Teens
  • Pregnancy

What will happen in the study?

This study includes 4 study visits over the next 3 months. There are 3 groups in this study – 2 groups will use formula and the 3rd group is a breastfeeding group. If your infant is being fed formula, you and your infant will be “randomized” - or put into a study group by chance - into 1 of 2 formula-fed groups, one of which will use the new ingredient.

Here are some of the things that will happen in this study:

We will:

  • Complete measurements including your baby’s length, weight and head circumference
  • Collect saliva samples from all babies and breastfeeding moms
  • Ask you to bring in one of your baby’s soiled diapers for a stool collection
  • Ask you to complete questionnaires about formula intake, if your baby has any stomach discomfort, crying time, and stool characteristics
  • Look for and evaluate if your baby has eczema
  • Ask you to complete a questionnaire about whether your baby has had any infections and medication

You will be given a consent form that thoroughly explains all of the details of the study. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.

What are the good things that can happen from this research?

Being in this study may not help your child directly. When we finish this study, we hope to learn more about how well an infant tolerates a formula that has a human milk oligosaccharide (HMO) added to it.

At each study visit, we will provide you with the length, weight and head circumference measurements of your infant.

What are the bad things that can happen from this research?

The ingredients and composition of the study formulas are considered safe and acceptable for use in the USA and Europe. However, just like any formula, your baby may not like the formula used in this study and drink little of it. Or, your baby may not tolerate the formula well (i.e. gas, vomiting). Frequently, these symptoms resolve themselves as babies get older and their gut matures. However, if severe, the study doctor may decide to remove you from the study if it would be in the best interest of your baby.

Will you/your child be paid to be in this research study?

Families will receive up to $400 for 4 study visits. If you are in a formula-fed group, you will receive the formula at no cost.

Contact

Contact Us.Andre Hawkins
stardust@cchmc.org
513-636-8549
Cincinnati Children’s Hospital Medical Center
3333 Burnet Ave.
Cincinnati, OH 45229-3039

Study Doctor

Contact Us.James Heubi, MD
Gastroenterology, Hepatology & Nutrition
Cincinnati Children’s Hospital Medical Center