Tolerance of Healthy, Term Infants to Infant Formulas

Phase 2

Completed

• Conditions: Healthy
• Interventions: Other: #3 Human Milk; Other: Milk based formula A; Other: #2 Standard formula; Other: Milk based formula C

• Registration Number: NCT00543673
• Lead Sponsor: Abbott Nutrition

Brief Summary

To assess the gastrointestinal tolerance of healthy full-term infants fed either experimental formula or a control formula

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-10-05
• Study First Submitted QC: 2007-10-12
• Study First Posted: 2007-10-15
• Primary Completion: 2008-05
• Status Verified: 2008-06
• Study Completion: 2008-06
• Last Update Submitted: 2008-07-03
• Last Update Posted: 2008-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• judged to be in good health.
• singleton from a full term birth with a gestational age of 37-42 weeks
• birth weight was > 2490 g (~5 lbs 8 oz)
• between 0 and 8 days of age at enrollment.
• Infant's parent(s) or a LAR has voluntarily signed and dated an 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 infant medical history thought by the investigator to have potential for effects on tolerance, growth, and/or development, including, but not limited to suspected maternal substance abuse.
• Infant has been treated with antibiotics.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reference	#3 Human Milk	Human milk
Milk based formula A	Milk based formula A	Experimental milk based infant formula
Standard formula	#2 Standard formula	standard milk based infant formula
Milk based formula C	Milk based formula C	Experimental milk based infant formula

Primary Outcome Measures

Name	Time	Method
Mean rank stool consistency (MRSC)	Study Day 1 to Visit 3

Secondary Outcome Measures

Name	Time	Method
MRSC, percent watery stools, average number of stools per day, percent of feedings with spit-up and/or vomiting	4 months

Trial Locations

Locations (10)

Midwest Children's Health Research Institute, LLC; 🇺🇸 Lincoln, Nebraska, United States

The Pediatric Clinic; 🇺🇸 North Little Rock, Arkansas, United States

USF; 🇺🇸 Tampa, Florida, United States

Medical Associates Clinic; 🇺🇸 Dubuque, Iowa, United States

Levine Childrens Hospital; 🇺🇸 Charlotte, North Carolina, United States

Institute of Clinical Research; 🇺🇸 Mayfield Heights, Ohio, United States

North Georgia Clinical Research, White's Pediatrics; 🇺🇸 Dalton, Georgia, United States

The Childrens Medical Group LLC; 🇺🇸 Poughkeepsie, New York, United States

Ohio Pediatrics, Inc.; 🇺🇸 Huber Heights, Ohio, United States

Scott & White Memorial Hospital; 🇺🇸 Temple, Texas, United States