Evaluation of Infants Fed an Extensively Hydrolyzed Infant Formula
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03884309 |
Recruitment Status :
Completed
First Posted : March 21, 2019
Last Update Posted : February 5, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Protein Intolerance | Other: Experimental Hydrolyzed Protein Infant Formula | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 48 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Tolerance, Compliance and Growth of Infants Fed an Extensively Hydrolyzed Infant Formula With Added Human Milk Oligosaccharides |
Actual Study Start Date : | March 25, 2019 |
Actual Primary Completion Date : | January 7, 2020 |
Actual Study Completion Date : | January 7, 2020 |

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 |
- Weight for Age [ Time Frame: Study Day 1 to Study Day 60 ]Change in weight for age z-score
- Gastrointestinal Tolerance [ Time Frame: Study Day 1 to Study Day 60 ]Parent completed diary questions
- Length [ Time Frame: Study Day 1 to Study Day 60 ]Gain measured in cm
- Head Circumference [ Time Frame: Study Day 1 to Study Day 60 ]Gain measured in cm

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Ages Eligible for Study: | up to 60 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884309
United States, Georgia | |
Paramount Research Solutions | |
College Park, Georgia, United States, 30349 | |
United States, Kentucky | |
Michael W. Simon, M.D., PSC | |
Nicholasville, Kentucky, United States, 40356 | |
United States, Nebraska | |
Midwest Children's Health Research Institute | |
Lincoln, Nebraska, United States, 68522 | |
United States, Tennessee | |
Memphis & Shelby County Pediatric Group | |
Memphis, Tennessee, United States, 38116 | |
United States, Texas | |
Ventavia Research Group, LLC | |
Houston, Texas, United States, 77008 | |
DCOL Center for Clinical Research | |
Longview, Texas, United States, 75605 |
Study Chair: | Barbara Marriage, PhD, RD | Abbott Nutrition |
Responsible Party: | Abbott Nutrition |
ClinicalTrials.gov Identifier: | NCT03884309 |
Other Study ID Numbers: |
AL32 |
First Posted: | March 21, 2019 Key Record Dates |
Last Update Posted: | February 5, 2020 |
Last Verified: | January 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |