NCT02640014

Brief Summary

The outcomes of oral immunotherapy (OIT) in food allergy study will provide more knowledge of oral immunotherapy. So far the OIT has showed in clinical experiments to be a interesting way to increase the unresponsiveness in severe food allergies. However little is known about it´s long-term outcomes, immunological mechanisms and there are no previous studies about cost-utility of OIT.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 28, 2015

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2023

Completed
Last Updated

May 5, 2026

Status Verified

May 1, 2026

Enrollment Period

6.8 years

First QC Date

December 17, 2015

Last Update Submit

May 4, 2026

Conditions

Food HypersensitivityImmune System DiseasesAnaphylaxis

Keywords

Food allergyHealth-related quality of life (HRQL)Quality-adjusted life-years (QALYs)Oral immunotherapy (OIT)Cow´s milk allergy (CMA)Milk oral immunotherapy (MOIT)

Outcome Measures

Primary Outcomes (1)

  • Long-term effectiveness as a measure of milk consumption (dl/day).

    Consumption of milk (dl/day)

    Ten years

Secondary Outcomes (4)

  • General health-related quality of life

    One year

  • Disease specific health-related quality of life

    One year

  • Cost-utility analysis and health benefits by measuring quality-adjusted life-years (QALYs).

    One year

  • Incidence of Treatment - Emergent Adverse Events

    Ten years

Study Arms (2)

Study 1: Milk OIT follow up

EXPERIMENTAL

Follow up on patient with severe milk allergy how have participated to milk OIT.

Dietary Supplement: Milk

Study 1: Follow up

NO INTERVENTION

Follow up on patient with severe milk allergy how have not participated to milk OIT.

Interventions

MilkDIETARY_SUPPLEMENT

Milk Oral immunotherapy

Study 1: Milk OIT follow up

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Study 1: All the children have been eligible to participate milk OIT during the years 2005-2015.
  • Study 2 + 3: Patients will start OIT treatment (to milk / egg / peanut).

You may not qualify if:

  • Not willing to participate
  • Active asthma, low lung function, pregnancy, cardiovascular or other disease that might worsen during the OIT.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Central Hospital, Skin and Allergy Hospital

Helsinki, 00029, Finland

Location

Related Publications (1)

  • Kauppila TK, Hinkkanen V, Savinko T, Karisola P, Kukkonen AK, Paassilta M, Pelkonen AS, Makela MJ. Long-term changes in milk component immunoglobulins reflect milk oral immunotherapy outcomes in Finnish children. Allergy. 2023 Feb;78(2):454-463. doi: 10.1111/all.15479. Epub 2022 Aug 20.

    PMID: 35969113DERIVED

MeSH Terms

Conditions

Food HypersensitivityImmune System DiseasesAnaphylaxis

Interventions

Milk

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivity

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Officials

  • Mika J Mäkelä, MD, PhD

    Chief Physician, Helsinki University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 17, 2015

First Posted

December 28, 2015

Study Start

December 1, 2015

Primary Completion

September 28, 2022

Study Completion

September 28, 2023

Last Updated

May 5, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)