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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02456805
Other study ID # AH23
Secondary ID
Status Completed
Phase N/A
First received May 27, 2015
Last updated May 27, 2015
Start date August 1996
Est. completion date June 1997

Study information

Verified date May 2015
Source Abbott Nutrition
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This study assessed tolerance improvement of a formula change in healthy term infants with perceived intolerance to their current milk-based formula feeding.


Recruitment information / eligibility

Status Completed
Enrollment 113
Est. completion date June 1997
Est. primary completion date June 1997
Accepts healthy volunteers No
Gender Both
Age group N/A to 9 Weeks
Eligibility Inclusion Criteria:

- Infants formula-fed exclusively and experiencing symptoms of cow's milk formula intolerance.

- Infants whose physicians had made a recommendation that the parents change the infant's feeding.

- Full term infants at birth with a gestational age of 37 to 42 weeks.

- Infants 2- 9 weeks of age at study entry with birth weights greater than 2500 grams.

Exclusion Criteria:

- Infants with a maternal medical history which had adverse effects on the fetus, such as diabetes, tuberculosis, perinatal infections, or substance abuse.

- Infants with evidence of cardiac, respiratory, gastrointestinal, hematological, or metabolic disease.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

Other:
Infant Formula 1
Feed ab libitum
Infant Formula 2
Feed ab libitum

Locations

Country Name City State
Canada Optimum Clinical Research Oshawa
United States Aurora Pediatric Associates Aurora Colorado
United States Clinical Studies, Inc Canton Ohio
United States The Medical Associates Clinic Dubuque Iowa
United States Arkansas Children's Hospital Little Rock Alaska
United States Richmond Pediatrics Richmond Virginia
United States Baystate Medical Center, Children's Hospital Springfield Massachusetts
United States Northlake Pediatric, Associates Stone Mountain Georgia

Sponsors (1)

Lead Sponsor Collaborator
Abbott Nutrition

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Stool Characteristics Parent questionnaire Change from Baseline (Study Day 1) to Study Day 15 No
Secondary Formula Intake Parent questionnaire on volume consumed Change from Baseline (Study Day 1) to Study Day 15 No
Secondary Incidence of spit up/vomiting Parent questionnaire Change from Baseline (Study Day 1) to Study Day 15 No
Secondary Weight Measured weight at visits Change from Baseline (Study Day 1) to Study Day 15 No
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