Infants Fed a Hydrolyzed Infant Formula

NCT05369494 | Completed

• 1 other identifier: AL49
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this non-randomized, multi-center study is to evaluate the growth, tolerance and compliance of an extensively hydrolyzed infant formula in an intended use population of infants.

Conditions

Gastrointestinal Tolerance

Outcome Measures

Primary Outcomes (1)

• Weight Maintenance

  Change in weight for age z-score

  Study Day1 to Study Day 28

Secondary Outcomes (3)

• Gastrointestinal Tolerance

  Study Day1 to Study Day 28

• Weight

  Study Day1 to Study Day 28

• Length

  Study Day1 to Study Day 28

Other Outcomes (5)

• Parent Perspectives Questionnaire

  Study Day1 to Study Day 28

• Formula Satisfaction Questionnaire

  Study Day1 to Study Day 28

• Infant Feeding and Stool Patterns Questionnaire

  Study Day1 to Study Day 28

Study Arms (1)

Experimental Product

EXPERIMENTAL

Infant formula product consumed ad libitum as instructed for approximately 28 days; Powder formula mixed to 20 kcal/fl. oz.

Other: Hydrolyzed protein infant formula with oligosaccharides

Interventions

Hydrolyzed protein infant formula with oligosaccharides OTHER

Hydrolyzed protein infant formula with oligosaccharides

Experimental Product

Eligibility Criteria

• Age: 0 Days - 90 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infant is 0 to 90 days of age at enrollment.
• Formula-fed Infant who is either experiencing persistent feeding intolerance, symptoms of suspected food protein allergy or currently consuming an extensively hydrolyzed formula (EHF) for symptoms of suspected food protein allergy, persistent feeding intolerance symptoms or other conditions where EHF is deemed an appropriate feeding by their health care professional
• Parent(s) of infants confirm their intention not to administer prescription medications, OTC medications, home remedies, prebiotics, probiotics, herbal preparations or rehydration fluids that might affect GI tolerance, unless their infants are currently consuming and have been directed by their healthcare professional to continue their use during the study
• 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 solid foods or juices to their infant from enrollment through the duration of the study
• Parent(s) confirm their intention not to administer vitamin or mineral supplements (with the exception of Vitamin D supplements) to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional
• Infant's parent(s) or a 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

You may not qualify if:

• An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on growth, and/or development
• Awareness of a positive drug screen in the mother or participant
• Suspected maternal substance abuse including alcohol
• Participation in another study that has not been approved as a concomitant study by AN
• Participant is receiving oral or inhaled steroids
• Participant has an allergy or intolerance to any ingredient in the study product, as reported by the parent
• Participant has received an amino acid-based formula

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (7)

Meridian Clinical Research, LLC

Washington D.C., District of Columbia, 20016, United States

Location

AdventHealth Medical Group Pediatrics

Orange City, Florida, 32763, United States

Location

Javara Inc.

Fayetteville, Georgia, 72703, United States

Location

Meridian Clinical Research 3259

Macon, Georgia, 31210, United States

Location

Springs Medical Research

Owensboro, Kentucky, 42303, United States

Location

Meridian Clinical Research 3357

Charleston, South Carolina, 29407, United States

Location

Gentle Pediatrics

Houston, Texas, 77084, United States

Location

MeSH Terms

Interventions

Oligosaccharides

Intervention Hierarchy (Ancestors)

Polysaccharides; Carbohydrates

Study Officials

• Carlett Ramirez

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 11, 2022
• Study Start: May 7, 2022
• Primary Completion: June 23, 2023
• Study Completion: November 18, 2023
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)