Evaluation of Infants Fed an Extensively Hydrolyzed Infant Formula

Completed · Not applicable

Conditions studied: Protein Intolerance

In brief

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.

Key facts

Study ID

NCT03884309

Run by

Abbott Nutrition

People needed

48

Starts

2019-03-25

Expected to finish

2020-01-07

Last updated by the study team

2020-02-05

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Paramount Research Solutions — College Park, Georgia, United States
• Michael W. Simon, M.D., PSC — Nicholasville, Kentucky, United States
• Midwest Children's Health Research Institute — Lincoln, Nebraska, United States
• Memphis & Shelby County Pediatric Group — Memphis, Tennessee, United States
• Ventavia Research Group, LLC — Houston, Texas, United States
• DCOL Center for Clinical Research — Longview, Texas, United States

Full record on ClinicalTrials.gov

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