Prevention of Cow's Milk Allergy in Children | NCT00792090

Studies
Prevention of Cow's Milk Allergy in Children

NCT00792090

Sponsor

Bledina

Status

Completed

Last Update Posted

Nov 17, 2008Estimated

Enrollment

142Actual

Phase

Not Applicable

Conditions

Milk Hypersensitivity

Interventions

Fermented milk
Standard milk

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

Nov 2008

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

Nov 2003

Primary Completion Date

May 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

Nov 14, 2008

First Submission Date that Met QC Criteria

Nov 14, 2008

First Posted Date

Nov 17, 2008Estimated

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

Nov 14, 2008

Last Update Posted Date

Nov 17, 2008Estimated

Name	Class
Optimed Medizinische Instrumente GmbH	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

142Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Fermented milk	Other: Fermented milk
2	Active Comparator	Standard milk	Other: Standard milk

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fermented milk	Other	Formula used for non breastfed children or in complement of breastfeeding	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensibilisation and cow's milk allergy		4, 12 and 24 months

Secondary Outcomes

Measure	Description	Time Frame
Sensitization or allergy to other allergens		4, 12 and 24 months
Atopic diseases (atopic dermatitis, asthma)		4, 12 and 24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

mother before the 5th month of pregnancy
mother agreeing to stop consumption of yogurts and fermented milks during the 3rd quarter of pregnancy
mother agreeing to receive a calcium supplementation during the 3rd quarter of pregnancy
atopic mother or father and at least another atopic member (sister or brother)
parents having given written informed consent
adhesion to eviction regimen for mother and child
parents agreeing with a regular follow-up (3 visits and monthly phone call with the dietician)

Exclusion Criteria:

mother in an exclusion period from another study
parents refusing to sign the informed consent
infant in a situation which could interfere with an optimal participation to the study, or which could represent a risk for the infant, according to the investigator
known or suspected immunodeficiency in the family

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christophe Dupont, PhD	Hôpital Saint Vincent de Paul	Principal Investigator
Denise-Anne Moneret-Vautrin, PhD	Hôpital central	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital central		Nancy		57000	France
Hôpital Saint Vincent de Paul

Condition Browse Module

MeSH Terms

ID	Term
D016269	Milk Hypersensitivity
D006967	Hypersensitivity

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D043302	Cultured Milk Products

Ancestor Terms

ID	Term
D008892	Milk
D001628	Beverages
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided