Clinical Trials

Infant Formula and toddler drink feeding

Posted on 9/23/2020
The purpose of this study is to evaluate the health and development outcomes of infants and toddlers fed an experimental milk-based infant formula and toddler drink with human milk oligosaccharides (HMOs) compared to similar (control) milk-based infant formula and toddler drink with HMOs.  

This study is a 24 month feeding study.  Parent(s) of formula fed participants agree to feed the assigned study product as the sole source of feeding for 4 months, with intent to continue feeding the study product to 12 months of age as the sole milk feeding and then a toddler dring as the primary milk feeding until 24 month of age. 

Parent(s) who plan to breast feed can also participate in the study if they agree to feed human milk as long as possible.  Should parent(s) decide to supplement with infant formula or wean from human milk, they agree to feed the infant the experimental supplemental/weaning formula provided to 12 months of age and then the experimental toddler drink as the primary milk feeding until 24 months of age.

The study duration is approximately 24 months and there will be 12 visits to the clinic. 

Your baby may qualify if he/she
  • is between 0 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 not been treated with antibiotics
  • does not have a medical history that may have effects on tolerance, growth and/or development

There will be no charge for participating in the study.  The study medication, 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 $60 for each study visit up to Visit 11 and $100 for Visit 12.  You will also be paid $25 for each monthly contact.

Call our office for more information - (903) 238-8854
What Our Research Patients are Saying
"I was on edge when I first went to DCOL Research because of the sensitive nature of my diagnosis. Upon arrival to the research office I was treated very kindly and professionally as soon as I signed in. The Research Coordinator was friendly and compassionate and made me feel at ease. I was informed about the trial and they ensured that I had a clear understanding of the information. During all my visits I felt at ease and informed. The Research Coordinator is very professional as is the Lab Coordinator. It is always a smooth process and the staff is confident and friendly. The study doctor is also helpful and always asks if I have any problems or concerns, just like the staff."

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