Acceptance Of A Partially-Hydrolyzed Infant Formula | NCT03223792

Studies
Acceptance Of A Partially-Hydrolyzed Infant Formula

NCT03223792

Sponsor

Mead Johnson Nutrition

Status

Completed

Last Update Posted

Jan 9, 2019Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Stool

Interventions

Control
Investigational

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

Jan 2019

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 21, 2017Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Jul 12, 2017

First Submission Date that Met QC Criteria

Jul 14, 2017

First Posted Date

Jul 21, 2017Actual

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

Jan 7, 2019

Last Update Posted Date

Jan 9, 2019Actual

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

Description Module

Brief Summary

This clinical trial will evaluate stool consistency in infants receiving one of two study formulas through a 14-day feeding period.

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

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Active Comparator		Other: Control
Investigational	Experimental		Other: Investigational

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Control	Other	Routine cow's milk-based infant formula	Control
Investigational

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stool consistency measured by MJN stool consistency scale		14 days

Secondary Outcomes

Measure	Description	Time Frame
Stool frequency		14 days
Formula acceptance measured by intake diary		14 days
Formula gastrointestinal tolerance measured by diary

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Singleton 28-300 days of age at randomization
Gestational age less than or equal to 35 weeks
Receiving minimum 18oz infant formula in the 24hrs prior to randomization
History of hard stools or stooling difficulty
Signed informed consent and protected health information

Exclusion Criteria:

Current diagnosis of cow's milk protein allergy or intolerance
Use of extensively hydrolyzed or amino acid formula at randomization
Any abdominal or gastrointestinal surgery prior to randomization
History of underlying metabolic or chronic disease or congenital malformation
Organic causes of constipation

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

28 Days

Maximum Age

300 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Steven Wu	Mead Johnson Nutrition	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Birmingham Pediatric Associates		Birmingham	Alabama	35205	United States
Southeastern Pediatric Associates

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided