NCT02083471

Brief Summary

Egg, milk and cereal allergies are the most important food allergies in Finnish children, the prevalence in western countries is 1-4 %. In some individuals food-allergy is maintained in to adulthood. Recent studies suggest that specific oral tolerance induction (SOTI) provides a treatment option in children with continuing allergy with high success rates. The study aims at specific oral tolerance induction in adults allergic to cow's milk or hen's egg. Oral immunotherapy involves taking very small amounts of the allergen, and slowly increasing the amount. Consequently, an elimination diet may be wholly or partially cancelled, without the fear of serious allergic reactions. Another aim is to explore changes in antibody-mediated and cell-mediated immune response to individual components of cow's milk and egg allergens during tolerance induction and compare these with the effect of the treatment.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

October 30, 2015

Status Verified

October 1, 2015

Enrollment Period

2.1 years

First QC Date

March 5, 2014

Last Update Submit

October 29, 2015

Conditions

Egg AllergyCow's Milk Allergy

Outcome Measures

Primary Outcomes (1)

  • Number of subjects with negative results

    12 months after commencement

Study Arms (2)

SOTI

ACTIVE COMPARATOR

Specific Oral Tolerance Induction with Egg or Cow's milk

Dietary Supplement: Specific Oral Tolerance Induction with Egg or Cow's milk

Food Allergy follow-up

NO INTERVENTION

Interventions

Specific Oral Tolerance Induction with Egg or Cow's milkDIETARY_SUPPLEMENT
SOTI

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Allergy to Egg or Cow's milk verified by challenge history and specific IgE

You may not qualify if:

  • Cardiovascular disease
  • Active immunological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Egg HypersensitivityMilk Hypersensitivity

Interventions

EggsMilk

Condition Hierarchy (Ancestors)

Food HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesBeveragesDairy Products

Study Officials

  • Johannes Savolainen, MD Professor

    University of Turku

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Johannes Savolainen, MD Professor

CONTACT

407172029johannes.savolainen@tyks.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2014

First Posted

March 11, 2014

Study Start

April 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

October 30, 2015

Record last verified: 2015-10