Tolerance of Healthy Term Infants Fed Infant Formulas #3

Gastrointestinal Tolerance Clinical Trial

Official title:

Tolerance of Healthy Term Infants Fed Infant Formulas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00977964
• Other study ID #: AK70
• Status: Completed
• Phase: Phase 3
• First received: September 15, 2009
• Last updated: November 24, 2010
• Start date: September 2009
• Est. completion date: January 2010

Study information

• Verified date: November 2010
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 8 Days

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Tolerance

Intervention

Other:
• Experimental milk protein infant formula Process A
ad lib for 1-8 days of age until 28 days of age
• Experimental milk protein infant formula Process B
ad lib from 1-8 days of age until 28 days of age
• Experimental milk protein infant formula Process C
ad lib from 1-8 days of age to 28 days of age
• Experimental milk protein infant formula Process D
ad lib from 1-8 days of age until 28 days of age
• Experimental milk protein infant formula Process E
ad lib from 1-8 days of age until 28 days of age
• Experimental milk protein infant formula Process F
ad lib from 1-8 days of age until 28 days of age

Locations

Country	Name	City	State
United States	Kentucky Pediatric / Adult Research	Bardstown	Kentucky
United States	Pediatric Associates of Mount Carmel, Inc	Cincinnati	Ohio
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	North Georgia Clinical Research	Dalton	Georgia
United States	Dayton Clinical Research	Dayton	Ohio
United States	Alabama Clinical Therapeutics	Dothan	Alabama
United States	Medical Associates Clinic, PC	Dubuque	Iowa
United States	Ohio Pediatric Research Association, Inc.	Huber Heights	Ohio
United States	Northpoint Pediatrics, LLC	Indianapolis	Indiana
United States	The Jackson Clinic, PA	Jackson	Tennessee
United States	Institute of Clinical Research	Mayfield Heights	Ohio
United States	All Women's Heatlthcare of West Broward, Inc: Discovery Clinical Research, Inc	Plantation	Florida
United States	Rockwood Clinic North - Pediatrics	Spokane	Washington
United States	SCORE Physician Alliance, LLC	St. Petersburg	Florida
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary variable is Gastrointestinal tolerance.		1-28 days of age	No
Secondary	The secondary variables are additional measures of GI tolerance and parental feedback.		1-28 days of age	No