Evaluation of Infants Fed an Extensively Hydrolyzed Infant Formula

Protein Intolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03884309
• Other study ID #: AL32
• Status: Completed
• Phase: N/A
• Start date: March 25, 2019
• Est. completion date: January 7, 2020

Study information

• Verified date: January 2020
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 7, 2020
• Est. primary completion date: January 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 60 Days

Eligibility

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.

Related Conditions & MeSH terms

• Protein Intolerance

Intervention

Other:
• Experimental Hydrolyzed Protein Infant Formula
fed ad libitum

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight for Age	Change in weight for age z-score	Study Day 1 to Study Day 60
Secondary	Gastrointestinal Tolerance	Parent completed diary questions	Study Day 1 to Study Day 60
Secondary	Length	Gain measured in cm	Study Day 1 to Study Day 60
Secondary	Head Circumference	Gain measured in cm	Study Day 1 to Study Day 60