Growth and Tolerance of Infants Fed Milk-Based Infant Formula

Gastro-Intestinal Tolerance Clinical Trial

Official title:

Growth and Tolerance of Young Infants Fed Milk-Based Infant Formula With Oligosaccharides

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03967132
• Other study ID #: AL29A
• Status: Completed
• Phase: N/A
• Start date: June 8, 2019
• Est. completion date: May 29, 2020

Study information

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

Clinical Trial Summary

The purpose of this study is to evaluate growth and tolerance of healthy term infants fed an experimental milk-based infant formula with oligosaccharides compared to a control milk-based infant formula.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: May 29, 2020
• Est. primary completion date: May 29, 2020
• 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.)

• If parent(s) of the participant elect to formula-feed the participant, parent(s) confirm the participant has not been given human milk since being discharged from the hospital following birth, and confirm their intention to feed their infant the study product as the sole source of feeding from Study Visit 1-Visit 7, unless instructed otherwise by their healthcare professional.

• If parent(s) of the participant elect to feed the infant human milk, they confirm the infant has not received any formula prior to enrollment, and confirm their intention to exclusively feed human milk from birth, and as the sole source of feeding from Study Visit 1-Visit 7.

• Parent(s) confirm their intention not to administer vitamin or mineral supplements (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional.

• Participant's parent(s) has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided 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 GI tolerance.

• Participant participates in another study that has not been approved as a concomitant study by AN.

Related Conditions & MeSH terms

• Gastro-Intestinal Tolerance

Intervention

Other:
• Control Infant Formula
Ready to feed infant formula, feed ad libitum
• Experimental Infant Formula
Ready to feed infant formula, feed ad libitum
• Reference Group
Human milk, breast feeding ad libitum

Locations

Country	Name	City	State
United States	ARC Clinical Research at Wilson Parke	Austin	Texas
United States	Deaconess Clinic, Inc.	Evansville	Indiana
United States	Ventavia Research Group, LLC	Fort Worth	Texas
United States	Ventavia Research Group	Houston	Texas
United States	Clinical Research Prime	Idaho Falls	Idaho
United States	Ventavia Research Group, LLC 3078	Keller	Texas
United States	Holston Medical Group	Kingsport	Tennessee
United States	Midsouth Center for Clinical Research	Memphis	Tennessee
United States	Institute of Clinical Research, LLC	Mentor	Ohio
United States	Phoenix Medical Research LLC	Miami	Florida
United States	The Cleveland Pediatric Research Center, LLC	Middleburg Heights	Ohio
United States	Michael W. Simon, M.D., PSC	Nicholasville	Kentucky
United States	Norwich Pediatric Group, P.C.	Norwich	Connecticut
United States	University Clinical Research-Deland, LLC a/b/a Accel Clinical Research	Orlando	Florida
United States	Springs Medical Research	Owensboro	Kentucky
United States	Kagan Pediatrics - HD Research Corporation	Pearland	Texas
United States	Plano Pediatrics - ACRC Trials	Plano	Texas
United States	Pediatric Medical Associates	Sacramento	California
United States	Watching Over Mothers & Babies	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Stool Sample	Microbiota characterization	Study Day 1 to Day of life 119
Primary	Weight	Weight gain per day	Day of life 14 - 119
Secondary	Stool Characteristics	Parent completed diary	Study Day 1 to Day of life 119
Secondary	Formula Tolerance	Parent completed diary	Study Day 1 to Day of life 119
Secondary	Length	Length gain per day	Study Day 1 to Day of life 119
Secondary	Head Circumference (HC)	HC gain per day	Study Day 1 to Day of life 119
Secondary	Illness Incidence	Parent reported incidence of illness	Study Day 1 to Day of life 119