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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00977964
Other study ID # AK70
Secondary ID
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


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
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