CompletedNCT02456805Updated May 29, 2015

Alternate Formula Feedings in Formula Intolerant Infants

An interventional study of Infant Formula 1 and Infant Formula 2 in Gastrointestinal Tolerance, sponsored by Abbott Nutrition. Completed at 8 sites in 2 countries. Open to participants aged 2 Weeks to 9 Weeks. Per ClinicalTrials.gov, last updated 2015-05-29.

Sponsored by Abbott Nutrition (part of Abbott) · Not applicable and Interventional

Phase: Not applicable
Study type: Interventional
Enrollment: 113
Allocation: Randomized
Ages: 2 Weeks to 9 Weeks
Sex: All

Study summary

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

Conditions studied

Gastrointestinal Tolerance

In context

Lead sponsor

Abbott Nutrition is the lead sponsor of 156 studies on the registry; 5 are open to participants now.

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Who can participate

Ages eligible: 2 Weeks to 9 Weeks
Sexes eligible: All
Accepts healthy volunteers: No

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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

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

Phase: Not applicable
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 113 participants (actual)

Study arms

Active comparator
Infant Formula 1
A standard commercial milk-based infant formula
Other: Infant Formula 1
Experimental
Infant Formula 2
A standard commercial soy-based infant formula.
Other: Infant Formula 2

Interventions

OtherInfant Formula 1
Feed ab libitum
OtherInfant Formula 2
Feed ab libitum

What researchers measure

Primary outcomes

Stool Characteristics
Parent questionnaire
Time frame: Change from Baseline (Study Day 1) to Study Day 15

Secondary outcomes

Formula Intake
Parent questionnaire on volume consumed
Time frame: Change from Baseline (Study Day 1) to Study Day 15
Incidence of spit up/vomiting
Parent questionnaire
Time frame: Change from Baseline (Study Day 1) to Study Day 15
Weight
Measured weight at visits
Time frame: Change from Baseline (Study Day 1) to Study Day 15

Study locations

8 sites

Arkansas Children's Hospital
Little Rock, Alaska 72202, United States
Aurora Pediatric Associates
Aurora, Colorado 80011, United States
Northlake Pediatric, Associates
Stone Mountain, Georgia 30087, United States
The Medical Associates Clinic
Dubuque, Iowa 52001, United States
Baystate Medical Center, Children's Hospital
Springfield, Massachusetts 01199, United States
Clinical Studies, Inc
Canton, Ohio 44709, United States
Richmond Pediatrics
Richmond, Virginia 23294, United States
Optimum Clinical Research
Oshawa, L1H, Canada

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 1996, a primary completion of Jun 1997 and a completion of Jun 1997. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: May 27, 2015
First posted: May 29, 2015
Start: Aug 1996
Primary completionActual: Jun 1997
CompletionActual: Jun 1997
Last update: May 29, 2015

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on May 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02456805
Lead sponsor: Abbott Nutrition
Responsible party: Sponsor
First posted: May 29, 2015
Start date: Aug 1996
Primary completion: Jun 1997
Completion: Jun 1997
Last update: May 29, 2015

Study contacts

John Lasekan, MBA, Ph.D, CCRP

study chair · Abbott Nutrition

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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