Safety of Oral Immunotherapy for Cow's Milk Allergy in Sc... | NCT01361347

Studies
Safety of Oral Immunotherapy for Cow's Milk Allergy in School-aged Children

NCT01361347

Sponsor

Tampere University Hospital

Status

Completed

Last Update Posted

Jan 4, 2017Estimated

Enrollment

28Actual

Phase

Phase 4

Conditions

Milk Allergy
Anaphylaxis

Interventions

milk

Countries

Finland

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 2017

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 2008

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Feb 24, 2011

First Submission Date that Met QC Criteria

May 25, 2011

First Posted Date

May 26, 2011Estimated

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 2, 2017

Last Update Posted Date

Jan 4, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marita Paassilta, MD, PhD, Paediatric Allergist, Tampere University HospitalPrincipal Investigator

Lead Sponsor

Tampere University HospitalOTHER

Collaborators

Not provided

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

Description Module

Brief Summary

The purpose of this study is to study the number of Participants with Adverse Events as a Measure of Safety and Tolerability.

Detailed Description

Eligibility criteria:

Age 6 - 16 yrs

IgE-mediated milk allergy
and milk provocation within 3 months prior to or an documented accidental milk contact with clear immediate symptoms

Outcome measures:

number of patients with successful desensitization (195 - 200 ml milk per day)
number of patients with adverse events

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
placebo	Placebo Comparator	rice/soy/oat "milk"drink, masked	Dietary Supplement: milk
milk	Experimental	cow's milk	Dietary Supplement: milk

Interventions

Name	Type	Description	Arm Group Labels	Other Names
milk	Dietary Supplement	milk for milk allergic children (1:25 dilution, whole milk)	milk placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with adverse events as a measure of safety and tolerability		12 months

Secondary Outcomes

Measure	Description	Time Frame
Number of participants drinking 2 dl/day of milk (success in desensitization)		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

IgE-mediated milk allergy
An immediately positive challenge test result to milk prior to inclusion

Exclusion Criteria:

Not willing to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marita Paassilta, MD, PhD	Consultant Pediatric Allergist	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tampere University Hospital, Allergy Centre		Tampere		FIN-33521	Finland

Condition Browse Module

MeSH Terms

ID	Term
D016269	Milk Hypersensitivity
D000707	Anaphylaxis

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008892	Milk
D003887	Desensitization, Psychologic

Ancestor Terms

ID	Term
D001628	Beverages
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D003611	Dairy Products

Browse Leaves

Not provided

Browse Branches

Not provided