Clinical Trials

Infant Formula Study for Growth and Tolerance

Posted on 9/8/2021

Proteins in infant formula can be intact (full-sized), partially hydrolyzed, or fully hydrolyzed.  Hydrolysis is a process that breaks down, or pre-digests protein so that the protein amino-acid chains are smaller and easier to digest for the infant.

The purpose of this research study is to compare the growth and tolerance of infants who consume either an infant formula with intact proteins or an infant formula with partially hydrolyzed proteins.

In this study infants will receive either:
  1. A routine cow's milk-based infant formula
  2. A partially hydrolyzed cow's milk protein (PHP) infant formula
Both of the study formulas are modified versions of currently marketed formulas.

Approximately 240 infants are expected to participate in this study.  The infant's participation will last until about 12 months of age.  There will be 9 visits to the research clinic to measure the infant's weight, length and head circumference.  There will be questions asked regarding the formula, stool characteristics and other important information.

Your baby may qualify if he/she
  • is between 10 and 14 days of age at enrollment
  • is a singleton from a full-term birth with a gestational age of 37-42 weeks
  • birth weight was at least 5 lbs. 8 oz.
  • has been exclusively formula fed for the past 24 hours prior to the screening visit
There will be no charge for participating in the study.  The infant formula, study materials and study specific visits will be provided at no charge to you or your insurance company. 

If you qualify and decide to participate you will be compensated for your time and travel while participating in the study.  You will receive $50 for each study visit for a total of $450 if all visits are completed.  You will be paid at the end of each study visit. 

Call our office for more information - (903) 238-8854
What Our Research Patients are Saying
"Last January I had to begin taking insulin for my diabetes. It was life changing for me. I had always been afraid of starting insulin. However, when I qualified for the diabetes clinical trial, it helped me accept this change in my life. The Research Coordinators are the very best you could ask for. They explained everything and let me know what to expect. I could never have controlled my diabetes if it hadn't been for this research program, the research staff and the study doctor. I would recommend participating in a research trial to anyone who has diabetes. It and the research staff are a godsend."
~ C.D

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