Gastrointestinal Tolerance of Infant Formula | NCT02322138

Studies
Gastrointestinal Tolerance of Infant Formula

NCT02322138

Sponsor

Abbott Nutrition

Status

Completed

Last Update Posted

Jul 23, 2015Estimated

Enrollment

131Actual

Phase

Not Applicable

Conditions

Gastrointestinal Tolerance

Interventions

Experimental 1 Infant Formula
Experimental 2 Infant Formula
Reference Group

Countries

United States

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

Jul 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

Jan 2015

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Dec 17, 2014

First Submission Date that Met QC Criteria

Dec 22, 2014

First Posted Date

Dec 23, 2014Estimated

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

Jul 22, 2015

Last Update Posted Date

Jul 23, 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

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

131Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental 1 Infant Formula	Experimental	Milk-based infant formula without prebiotics	Other: Experimental 1 Infant Formula
Experimental 2 Infant Formula	Experimental	Milk-based infant formula with prebiotics	Other: Experimental 2 Infant Formula
Human Milk-Fed Reference Group	Other	Breast fed infants	Other: Reference Group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Experimental 1 Infant Formula	Other	Ready to feed infant formula to be fed ad-libitum	Experimental 1 Infant Formula

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stool Consistency Questionnaire	Questionnaire	Baseline to 35 Days of Age

Secondary Outcomes

Measure	Description	Time Frame
Stools per Day Questionnaire	Questionnaire	Baseline to 35 Days of Age
Feeding Spit Up Questionnaire	Questionnaire	Baseline to 35 Days of Age

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Infant is judged to be in good health.
Infant is a singleton from a full term birth with a gestational age of 37-42 weeks.
Infant's birth weight was > 2490 g (~5 lbs 8 oz.).
Infant is between 0 and 8 days of age at enrollment.
Parent(s) confirm their intention to feed their infant the study product (formula-fed infants) or human milk (human milk-fed infants) as the sole source of nutrition for the duration of the study.
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.

Exclusion Criteria:

Adverse maternal, fetal or infant medical history that effects tolerance, growth, and/or development.
Infants using medications, home remedies, herbal preparations, probiotics or rehydration fluids that might affect GI tolerance.
Mother intends to use a combination of breast and formula feeding.
Participation in another study that has not been approved as a concomitant study by AN.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

8 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Janice Kajzer, MS, RD, LD	Abbott Nutrition	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
W.O.M.B Watching Over Mothers and Babies		Tucson	Arizona	85712	United States
Clinical Research Advantage/Colorado Springs Health Partners