Tolerance of Healthy Term Infants Fed Infant Formulas #3

Phase 3

Completed

• Conditions: Gastrointestinal Tolerance
• Interventions: Other: Experimental milk protein infant formula Process A; Other: Experimental milk protein infant formula Process B; Other: Experimental milk protein infant formula Process C; Other: Experimental milk protein infant formula Process D; Other: Experimental milk protein infant formula Process E; Other: Experimental milk protein infant formula Process F

• Registration Number: NCT00977964
• Lead Sponsor: Abbott Nutrition

Brief Summary

The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to six experimental milk protein-based powdered infant formulas.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-15
• Study First Submitted QC: 2009-09-15
• Study First Posted: 2009-09-16
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-24
• Last Update Posted: 2010-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

• Infant is judged to be in good health.
• Infant is a singleton from a full term birth.
• Infant's birth weight was > 2490 g (~5 lbs 8 oz.
• Infant is between 0 and 8 days of age at enrollment.
• Infants using medications, home remedies ,herbal preparations or rehydration fluids that might affect GI tolerance may not be enrolled.
• Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional.

Exclusion Criteria

• An adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
• Infant has been treated with antibiotics.
• Infant has received probiotics.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Milk Based Protein Formula Process A	Experimental milk protein infant formula Process A	-
Milk Based Protein Formula Process B	Experimental milk protein infant formula Process B	-
Milk Based Protein Formula Process C	Experimental milk protein infant formula Process C	-
Milk Based Protein Formula Process D	Experimental milk protein infant formula Process D	-
Milk Based Protein Formula Process E	Experimental milk protein infant formula Process E	-
Milk Based Protein Formula Process F	Experimental milk protein infant formula Process F	-

Primary Outcome Measures

Name	Time	Method
The primary variable is Gastrointestinal tolerance.	1-28 days of age

Secondary Outcome Measures

Name	Time	Method
The secondary variables are additional measures of GI tolerance and parental feedback.	1-28 days of age

Trial Locations

Locations (15)

University of South Florida; 🇺🇸 Tampa, Florida, United States

The Jackson Clinic, PA; 🇺🇸 Jackson, Tennessee, United States

MetroHealth Medical Center; 🇺🇸 Cleveland, Ohio, United States

North Georgia Clinical Research; 🇺🇸 Dalton, Georgia, United States

All Women's Heatlthcare of West Broward, Inc: Discovery Clinical Research, Inc; 🇺🇸 Plantation, Florida, United States

SCORE Physician Alliance, LLC; 🇺🇸 St. Petersburg, Florida, United States

Alabama Clinical Therapeutics; 🇺🇸 Dothan, Alabama, United States

Northpoint Pediatrics, LLC; 🇺🇸 Indianapolis, Indiana, United States

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

Dayton Clinical Research; 🇺🇸 Dayton, Ohio, United States

Kentucky Pediatric / Adult Research; 🇺🇸 Bardstown, Kentucky, United States

Pediatric Associates of Mount Carmel, Inc; 🇺🇸 Cincinnati, Ohio, United States

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

Rockwood Clinic North - Pediatrics; 🇺🇸 Spokane, Washington, United States

Ohio Pediatric Research Association, Inc.; 🇺🇸 Huber Heights, Ohio, United States