Evaluation of Infants Fed an Extensively Hydrolyzed Infant Formula
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental Hydrolyzed Protein Infant Formula hydrolyzed protein infant formula powder in cans |
Other: Experimental Hydrolyzed Protein Infant Formula
fed ad libitum
|
Outcome Measures
Primary Outcome Measures
- Weight for Age [Study Day 1 to Study Day 60]
Change in weight for age z-score
Secondary Outcome Measures
- Gastrointestinal Tolerance [Study Day 1 to Study Day 60]
Parent completed diary questions
- Length [Study Day 1 to Study Day 60]
Gain measured in cm
- Head Circumference [Study Day 1 to Study Day 60]
Gain measured in cm
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Paramount Research Solutions | College Park | Georgia | United States | 30349 |
| 2 | Michael W. Simon, M.D., PSC | Nicholasville | Kentucky | United States | 40356 |
| 3 | Midwest Children's Health Research Institute | Lincoln | Nebraska | United States | 68522 |
| 4 | Memphis & Shelby County Pediatric Group | Memphis | Tennessee | United States | 38116 |
| 5 | Ventavia Research Group, LLC | Houston | Texas | United States | 77008 |
| 6 | DCOL Center for Clinical Research | Longview | Texas | United States | 75605 |
Sponsors and Collaborators
- Abbott Nutrition
Investigators
- Study Chair: Barbara Marriage, PhD, RD, Abbott Nutrition
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AL32