MedPath

Tolerance of Healthy, Term Infants to Infant Formulas

Phase 2
Completed
Conditions
Healthy
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

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
Primary Outcome Measures
NameTimeMethod
Mean rank stool consistency (MRSC)Study Day 1 to Visit 3
Secondary Outcome Measures
NameTimeMethod
MRSC, percent watery stools, average number of stools per day, percent of feedings with spit-up and/or vomiting4 months

Trial Locations

Locations (10)

The Pediatric Clinic

🇺🇸

North Little Rock, Arkansas, United States

USF

🇺🇸

Tampa, Florida, United States

North Georgia Clinical Research, White's Pediatrics

🇺🇸

Dalton, Georgia, United States

Medical Associates Clinic

🇺🇸

Dubuque, Iowa, United States

Midwest Children's Health Research Institute, LLC

🇺🇸

Lincoln, Nebraska, United States

The Childrens Medical Group LLC

🇺🇸

Poughkeepsie, New York, United States

Levine Childrens Hospital

🇺🇸

Charlotte, North Carolina, United States

Ohio Pediatrics, Inc.

🇺🇸

Huber Heights, Ohio, United States

Institute of Clinical Research

🇺🇸

Mayfield Heights, Ohio, United States

Scott & White Memorial Hospital

🇺🇸

Temple, Texas, United States

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

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