Clinical trial NCT03884309: Evaluation of Infants Fed an Extensively Hydrolyzed Infant Formula
Official title: Tolerance, Compliance and Growth of Infants Fed an Extensively Hydrolyzed Infant Formula With Added Human Milk Oligosaccharides
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Protein Intolerance
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2019-03-21
Enrollment: 48
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Weight for Age
timeFrame: Study Day 1 to Study Day 60
Secondary outcomes:
measure: Gastrointestinal Tolerance
timeFrame: Study Day 1 to Study Day 60
measure: Length
timeFrame: Study Day 1 to Study Day 60
measure: Head Circumference
timeFrame: Study Day 1 to Study Day 60
Other outcomes:
Locations:
city: College Park
country: United States
facility: Paramount Research Solutions
state: Georgia
city: Nicholasville
country: United States
facility: Michael W. Simon, M.D., PSC
state: Kentucky
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute
state: Nebraska
city: Memphis
country: United States
facility: Memphis & Shelby County Pediatric Group
state: Tennessee
city: Houston
country: United States
facility: Ventavia Research Group, LLC
state: Texas
city: Longview
country: United States
facility: DCOL Center for Clinical Research
state: Texas
Study officials:
affiliation: Abbott Nutrition
name: Barbara Marriage, PhD, RD
role: STUDY_CHAIR
References: