Alternate Formula Feedings in Formula Intolerant Infants | NCT02456805

Studies
Alternate Formula Feedings in Formula Intolerant Infants

NCT02456805

Sponsor

Abbott Nutrition

Status

Completed

Last Update Posted

May 29, 2015Estimated

Enrollment

113Actual

Phase

Not Applicable

Conditions

Gastrointestinal Tolerance

Interventions

Infant Formula 1
Infant Formula 2

Countries

United States
Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1996

Primary Completion Date

Jun 1997Actual

Completion Date

Jun 1997Actual

First Submitted Date

May 27, 2015

First Submission Date that Met QC Criteria

May 27, 2015

First Posted Date

May 29, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2015

Last Update Posted Date

May 29, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

113Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Infant Formula 1	Active Comparator	A standard commercial milk-based infant formula	Other: Infant Formula 1
Infant Formula 2	Experimental	A standard commercial soy-based infant formula.	Other: Infant Formula 2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Infant Formula 1	Other	Feed ab libitum	Infant Formula 1
Infant Formula 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stool Characteristics	Parent questionnaire	Change from Baseline (Study Day 1) to Study Day 15

Secondary Outcomes

Measure	Description	Time Frame
Formula Intake	Parent questionnaire on volume consumed	Change from Baseline (Study Day 1) to Study Day 15
Incidence of spit up/vomiting	Parent questionnaire

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Weeks

Maximum Age

9 Weeks

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Lasekan, MBA, Ph.D, CCRP	Abbott Nutrition	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arkansas Children's Hospital		Little Rock	Alaska	72202	United States
Aurora Pediatric Associates