Infants Fed a Hydrolyzed Infant Formula

Gastrointestinal Tolerance Clinical Trial

Official title:

Tolerance of Infants Fed a Hydrolyzed Infant Formula

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05369494
• Other study ID #: AL49
• Status: Completed
• Phase: N/A
• Start date: May 7, 2022
• Est. completion date: November 18, 2023

Study information

• Verified date: April 2024
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 18, 2023
• Est. primary completion date: June 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 90 Days

Eligibility

Inclusion Criteria:

• 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

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

• 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

Related Conditions & MeSH terms

• Gastrointestinal Tolerance

Intervention

Other:
• Hydrolyzed protein infant formula with oligosaccharides
Hydrolyzed protein infant formula with oligosaccharides

Locations

Country	Name	City	State
United States	Meridian Clinical Research 3357	Charleston	South Carolina
United States	Javara Inc.	Fayetteville	Georgia
United States	Gentle Pediatrics	Houston	Texas
United States	Meridian Clinical Research 3259	Macon	Georgia
United States	AdventHealth Medical Group Pediatrics	Orange City	Florida
United States	Springs Medical Research	Owensboro	Kentucky
United States	Meridian Clinical Research, LLC	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Parent Perspectives Questionnaire	Parent completed questionnaire; 4, 5-point Likert scale questions, scaled from negative to positive with higher scores indicating better perception	Study Day1 to Study Day 28
Other	Formula Satisfaction Questionnaire	Parent completed questionnaire; 13 questions of up to 5 categories, scaled from positive to negative	Study Day1 to Study Day 28
Other	Infant Feeding and Stool Patterns Questionnaire	Parent completed questionnaire; 16, 5-point Likert scale questions, scaled from always to never	Study Day1 to Study Day 28
Other	Health Care Utilization	Number of Visits	Study Day1 to Study Day 28
Other	Adverse Events	Parent reported adverse events	Study Day1 to Study Day 28
Primary	Weight Maintenance	Change in weight for age z-score	Study Day1 to Study Day 28
Secondary	Gastrointestinal Tolerance	Parent completed diary	Study Day1 to Study Day 28
Secondary	Weight	Weight gain per day in grams	Study Day1 to Study Day 28
Secondary	Length	Length gain per day in cm	Study Day1 to Study Day 28