Evaluation of Infants Fed an Extensively Hydrolyzed Infant Formula

Not Applicable

Completed

• Conditions: Protein Intolerance
• Interventions: Other: Experimental Hydrolyzed Protein Infant Formula

• Registration Number: NCT03884309
• Lead Sponsor: Abbott Nutrition

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-18
• Study First Submitted QC: 2019-03-19
• Study First Posted: 2019-03-21
• Study Start: 2019-03-25
• Status Verified: 2020-01
• Primary Completion: 2020-01-07
• Study Completion: 2020-01-07
• Last Update Submitted: 2020-01-31
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Hydrolyzed Protein Infant Formula	Experimental Hydrolyzed Protein Infant Formula	hydrolyzed protein infant formula powder in cans

Primary Outcome Measures

Name	Time	Method
Weight for Age	Study Day 1 to Study Day 60	Change in weight for age z-score

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal Tolerance	Study Day 1 to Study Day 60	Parent completed diary questions
Head Circumference	Study Day 1 to Study Day 60	Gain measured in cm
Length	Study Day 1 to Study Day 60	Gain measured in cm

Trial Locations

Locations (6)

Paramount Research Solutions; 🇺🇸 College Park, Georgia, United States

Midwest Children's Health Research Institute; 🇺🇸 Lincoln, Nebraska, United States

Michael W. Simon, M.D., PSC; 🇺🇸 Nicholasville, Kentucky, United States

Memphis & Shelby County Pediatric Group; 🇺🇸 Memphis, Tennessee, United States

DCOL Center for Clinical Research; 🇺🇸 Longview, Texas, United States

Ventavia Research Group, LLC; 🇺🇸 Houston, Texas, United States