Evaluation of Infants Fed an Extensively Hydrolyzed Infant Formula



Status:Not yet recruiting
Healthy:No
Age Range:Any
Updated:3/23/2019
Start Date:April 2019
End Date:October 2019
Contact:Kristen DeLuca, MS, RDN, LD
Email:kristen.deluca@abbott.com
Phone:614-624-5455

Use our guide to learn which trials are right for you!

Tolerance, Compliance and Growth of Infants Fed an Extensively Hydrolyzed Infant Formula With Added Human Milk Oligosaccharides

This is a single group, non-randomized, multicenter study to assess the effects of a
hypoallergenic casein hydrolysate powdered infant formula on gastrointestinal (GI) tolerance,
growth and compliance in an intended use infant population.


Inclusion Criteria:

- Participant is presently consuming an extensively hydrolyzed infant formula (EHF) for
persistent feeding intolerance symptoms, symptoms of suspected food protein (milk
and/or soy) sensitivity, or other conditions where EHF is deemed an appropriate
feeding.

- Parent(s) of infants confirm their intention not to administer prescription
medications, over the counter medications, home remedies, prebiotics, probiotics,
herbal preparations or rehydration fluids that might affect GI tolerance.

- Parent(s) confirm their intention to feed their infant the study product as the sole
source of nutrition for the duration of the study.

- Parent(s) confirm their intention not to administer vitamins, minerals (with the
exception of Vitamin D supplements), solid foods or juices to their infant from
enrollment through the duration of the study.

- Participant's parent(s) or a legally authorized representative (LAR) has voluntarily
signed and dated an informed consent form (ICF) approved by an Independent Ethics
Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance
Portability and Accountability Act (HIPAA) (or other applicable privacy regulation)
authorization prior to any participation in the study.

Exclusion Criteria:

- An adverse maternal, fetal or participant medical history that is thought by the
investigator to have potential for effects on growth, and/or development.

- Participant is receiving oral or inhaled steroids.

- Participant participates in another study that has not been approved as a concomitant
study.

- Participant has an allergy or intolerance to any ingredient in the study product.

- Participant has been treated with antibiotics or other medications that in the opinion
of the PI may affect growth, GI tolerance and/or development, within 2 weeks prior to
enrollment.
We found this trial at
5
sites
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
707 Hollybrook Drive
Longview, Texas 75605
903-238-8854
?
mi
from
Longview, TX
Click here to add this to my saved trials
Houston, Texas 77389
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Memphis, TN
Click here to add this to my saved trials
Nicholasville, Kentucky 40356
?
mi
from
Nicholasville, KY
Click here to add this to my saved trials