Soy Formula Feedings in Healthy, Term Infants

Gastrointestinal Tolerance Clinical Trial

Official title:

Efficacy of Soy Formula Feedings in Healthy, Term Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02456831
• Other study ID #: AE58
• Status: Completed
• Phase: N/A
• First received: May 27, 2015
• Last updated: May 28, 2015
• Start date: December 1992
• Est. completion date: June 1994

Study information

• Verified date: May 2015
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study evaluates the GI tolerance and acceptability of soy formulas fed to healthy term infants with reported intolerance to a milk-based formula.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: June 1994
• Est. primary completion date: June 1994
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 9 Weeks

Eligibility

Inclusion Criteria:

• Healthy infants believed by their parents and/or physicians to be experiencing symptoms of cow's milk formula intolerance and who had not previously consumed a soy-based formula (Intervention subjects).

• Health infants reported to be tolerating a milk-based formula (Cohorts).

• Infants considered full-term, 2 to 9 weeks of age with a birth-weight above the 5th percentile (NCHS).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Gastrointestinal Tolerance

Intervention

Other:
• Experimental Infant Formula 1
method A phytate reduction and 5% protein hydrolysis
• Experimental Infant Formula 2
method A phytate reduction and 10% protein hydrolysis
• Experimental Infant Formula 3
method B phytate reduction and 5% protein hydrolysis
• Active Comparator: Control Infant Formula
Ready-to-Feed (RTF) Soy Infant Formula

Locations

Country	Name	City	State
United States	Dreyer Clinic	Aurora	Illinois
United States	Clinical Studies, Inc	Canton	Ohio
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	Research Memphis	Memphis	Tennessee
United States	Park Nicollet Medical Foundation	Minneapolis	Minnesota
United States	T&W Research	Owensboro	Kentucky
United States	Child Care Associates	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stool Characteristics Questionnaire	stool number, consistency, and color	Change from Baseline (Study Day 1) to Study Day 15	No
Secondary	Formula Intake	volume consumed	Change from Baseline (Study Day 1) to Study Day 15	No
Secondary	Gastrointestinal Tolerance Questionnaire	Incidence of spit up and vomiting	Change from Baseline (Study Day 1) to Study Day 15	No
Secondary	Weight	weight and weight gain	Change from Baseline (Study Day 1) to Study Day 15	No