Evaluation of the Efficacy of an Amino Acid Based Formula... | NCT01584245

Studies
Evaluation of the Efficacy of an Amino Acid Based Formula in Infants

NCT01584245

Sponsor

Mead Johnson Nutrition

Status

Terminated

Last Update Posted

Sep 16, 2014Estimated

Enrollment

32Actual

Phase

Not Applicable

Conditions

Cow's Milk Allergy

Interventions

Amino Acid formula

Countries

France

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

Sep 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Enough participants enrolled to provide adequate statistical power

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Apr 23, 2012

First Submission Date that Met QC Criteria

Apr 23, 2012

First Posted Date

Apr 24, 2012Estimated

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

Sep 15, 2014

Last Update Posted Date

Sep 16, 2014Estimated

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

32Actual

Name	Type	Description	Arm Group Labels	Other Names
Amino Acid formula	Other

Measure	Description	Time Frame
Weight gain		12 weeks

Measure	Description	Time Frame
Allergic manifestations		12 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Weight loss within the past 4 weeks
Infants 1-12 months of age feeding a hypoallergenic formula for at least 2 weeks
Birth weight greater than or equal to 1500 grams
Solely enteral fed
Infants with at least one persistent allergy symptom
No change in medication within 10 days of beginning the study and no plans for change during the first 10 days of the study
Signed informed consent

Exclusion Criteria:

History of underlying condition which, in the Investigator's opinion, could interfere with normal growth, development, or assessment of the participant
Metabolic disease requiring special attention

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

12 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Delphine de Boissieu, M.D.	Centre médical	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre médical		Boulogne-Billancourt			France
Hôpital Saint Vincent de Paul

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27526059	Derived	Vanderhoof J, Moore N, de Boissieu D. Evaluation of an Amino Acid-Based Formula in Infants Not Responding to Extensively Hydrolyzed Protein Formula. J Pediatr Gastroenterol Nutr. 2016 Nov;63(5):531-533. doi: 10.1097/MPG.0000000000001374.

ID	Term
D005512	Food Hypersensitivity
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases