Alternate Formula Feedings in Formula Intolerant Infants

Gastrointestinal Tolerance Clinical Trial

Official title:

Efficacy of Alternate Formula Feedings in Formula Intolerant Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02456805
• Other study ID #: AH23
• 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

• Gastrointestinal Tolerance

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