Efficacy of a New Thickened Extensively Hydrolyzed Formula | NCT01985607

Studies
Efficacy of a New Thickened Extensively Hydrolyzed Formula

NCT01985607

Sponsor

United Pharmaceuticals

Status

Completed

Last Update Posted

Mar 24, 2015Estimated

Enrollment

72Estimated

Phase

Not Applicable

Conditions

Protein Allergy
Cow's Milk Protein Hypersensitivity

Interventions

new extensively hydrolysed formula
Extensively hydrolysed formula

Countries

Belgium
Greece
Kuwait
Lebanon
Slovenia

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

Mar 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

Feb 2011

Primary Completion Date

Jul 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Nov 8, 2013

First Submission Date that Met QC Criteria

Nov 14, 2013

First Posted Date

Nov 15, 2013Estimated

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

Mar 20, 2015

Last Update Posted Date

Mar 24, 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

Cow Milk Allergy (CMA) occurs in 2 to 5 % of all infants. Reflux, regurgitation and vomiting are well recognised symptoms of CMA. The recommended treatment of CMA is an extensive hydrolysate. The North American Society of Pediatric Gastroenterology Hepatology and Nutrition (NASPGHAN) & the European Society of Pediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) reflux guidelines have no strict recommendations for the treatment of distressed infants with reflux, suspected of CMA. One of the preferred proposed options is to thicken an extensive hydrolysate .

This study aims at evaluating the additional value of a thickened extensive hydrolysate in children suspected of CMA and presenting with frequent regurgitation.

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

72Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Thickened	Experimental		Dietary Supplement: new extensively hydrolysed formula
Control	Active Comparator		Dietary Supplement: Extensively hydrolysed formula

Interventions

Name	Type	Description	Arm Group Labels	Other Names
new extensively hydrolysed formula	Dietary Supplement		Thickened
Extensively hydrolysed formula

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patient dropped out for intolerance		1 month
Vandenplas' regurgitations score		1 month

Secondary Outcomes

Measure	Description	Time Frame
Cow's milk protein hypersensitivity score		1 month
Growth (weight, height, head circumference)		1 month
Growth (weight, height, head circumference)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

term born infants
Having a Vandenplas' score of regurgitation of at least 2
With suspected diagnosis of CMA because of clinical history/symptoms (based on a Cow's Milk Protein hypersensitivity (CMPH) score of 10 or more) and/or positive Immunoglobulin E (IgE) testing, radioallergosorbent test (RAST) or skin prick test

Exclusion Criteria:

Exclusively breast fed infants
Fed with an extensively hydrolysed formula or amino acid formula

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

6 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitair Ziekenhuis Brussel		Brussels			Belgium
Hippocration Hospital