Healthy Term Infants Fed Milk-Based Infant Formula

Tolerance Clinical Trial

Official title:

Tolerance of Healthy Term Infants Fed Milk-Based Infant Formula With Oligosaccharides

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04529759
• Other study ID #: AL39
• Status: Completed
• Phase: N/A
• Start date: September 12, 2020
• Est. completion date: June 18, 2021

Study information

• Verified date: July 2021
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, controlled, double-blind, parallel, feeding study with the purpose to evaluate the tolerance of healthy term infants fed partially hydrolyzed whey protein infant formulas.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: June 18, 2021
• Est. primary completion date: June 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 14 Days

Eligibility

Inclusion Criteria:

• Good health as determined from participant's medical history

• Singleton from a full-term birth with a gestational age of 37-42 weeks

• Birth weight was > 2490 g (~5 lbs. 8 oz.)

• 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 vitamin or mineral supplements, (except for vitamin D supplements if instructed by their healthcare professional), solid foods or juices to their infant from enrollment through the duration of the study

• Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) 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 tolerance, growth, and/or development

• Participant is taking and plans to continue taking medications (including over the counter (OTC), such as Mylicon® for gas), prebiotics, probiotics, home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance

• Participant is enrolled in another study that has not been approved as a concomitant study

Related Conditions & MeSH terms

• Tolerance

Intervention

Other:
• Control Infant Formula
Powdered partially hydrolyzed whey (WPH) based formula with an oligosaccharide
• Experimental Infant Formula
Powdered partially hydrolyzed whey (WPH) based formula with oligosaccharides blend

Locations

Country	Name	City	State
United States	Midsouth Center for Clinical Research	Memphis	Tennessee
United States	Institute of Clinical Research	Mentor	Ohio
United States	Springs Medical Research	Owensboro	Kentucky
United States	PAS Research, LLC	Tampa	Florida
United States	Visions Clinical Research	Tucson	Arizona
United States	The Cleveland Pediatric Research Center, LLC	Westlake	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Infant Stool Characteristics	Parent Completed Diary	Study Day 1 to 119 Days of Age
Other	Study Product Intake	Parent Completed Diary	Study Day 1 to 119 Days of Age
Other	Infant and Household Characteristics	Parent reported lifestyle and illness questions	Study Day 1 to 119 Days of Age
Other	Health Resource Utilization	Number of Visits	Study Day 1 to 119 Days of Age
Other	Infant Feeding and Stool Patterns Questionnaire	Parent completed questionnaire; 16, 5-point Likert scale questions, scaled in the negative direction	Exit or 119 Days of Age
Other	Infant Behavior Questionnaire	Parent completed questionnaire; 22 questions with 5-point Likert scale questions; scaled in the negative direction	Exit or 119 Days of Age
Other	Formula Satisfaction Questionnaire	Parent completed questionnaire; 13 questions of up to 5 categories scaled in the negative direction	Exit or 119 Days of Age
Other	Adverse Events	Standard adverse event reporting	Study Day 1 to 119 Days of Age
Primary	Mean rank stool consistency (MRSC)	Parent Completed Diary	Study Day 1 to 28 Days of Age
Secondary	Weight	Interval weight gain per day	14 to 119 Days of Age
Secondary	Gastrointestinal tolerance	Parent Completed Diary	14 to 119 Days of Age
Secondary	Length	Interval length gain per day	14 to 119 Days of Age
Secondary	Head Circumference	Interval head circumference gain per day	14 to 119 Days of Age