Tolerance of Infants Fed a Hydrolysate Formula | NCT03628183

Studies
Tolerance of Infants Fed a Hydrolysate Formula

NCT03628183

Sponsor

Abbott Nutrition

Status

Completed

Last Update Posted

Dec 19, 2018Actual

Enrollment

51Actual

Phase

Not Applicable

Conditions

Gastrointestinal Tolerance

Interventions

Hydrolysate Infant Formula 1
Hydrolysate Infant Formula 2

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

Dec 2018

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 28, 2018Actual

Primary Completion Date

Nov 23, 2018Actual

Completion Date

Nov 23, 2018Actual

First Submitted Date

Jul 13, 2018

First Submission Date that Met QC Criteria

Aug 9, 2018

First Posted Date

Aug 14, 2018Actual

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

Dec 17, 2018

Last Update Posted Date

Dec 19, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

51Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hydrolysate Infant Formula 1	Active Comparator	Ready to feed infant formula in can	Other: Hydrolysate Infant Formula 1
Hydrolysate Infant Formula 2	Experimental	Ready to feed infant formula in bottle	Other: Hydrolysate Infant Formula 2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hydrolysate Infant Formula 1	Other	Feed ad lib	Hydrolysate Infant Formula 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stool Characteristics	Parent completed diary	Study Day 1 - Study Day 21

Secondary Outcomes

Measure	Description	Time Frame
Formula Intake	Parent completed diary	Study Day 1 - Study Day 21
Weight	Scale	Study Day 1 - Study Day 21

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is judged to be in good health
Singleton from a full-term birth
Birth weight was > or = to 2490 g
Between 0 and 14 days of age at enrollment
Parent(s) confirm their intention to feed their infant the assigned study product 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
Subject's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF)

Exclusion Criteria:

An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
Subject is taking and plans to continue medications, home remedies, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance
Subject participates in another study that has not been approved as a concomitant study
Subject has an allergy or intolerance to any ingredient in the study product
Subject has been treated with antibiotics within 2 weeks prior to enrollment

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

14 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Courtney Allgeier, MS, RD, LD	Abbott Nutrition	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Watching Over Mothers and Babies		Tucson	Arizona	85712	United States
Springs Medical Research

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided