Food Hypersensitivity
Conditions
Brief summary
This general population based, randomized controled trial aims at answering two major hypotheses: First, systematic early introduction of solid foods decreases the incidence of food allergy and dietary restrictions by the age of one year. Second, stimulation with the symptom-eliciting food rather than avoidance will induce tolerance in babies with non-severe allergic symptoms.
Detailed description
All new born babies living in the city of Oulu are recruited to the study (n=1380) at their first health nurse visit (at or before 1 month of age) in the local primary care child health clinics. Families in the intervention group will get an instruction booklet including information on early systematic introduction of solid foods starting at the age of 4 months, with foodstuff from all major groups in diet by the age of 6 months (vegetables and fruits, wheat and other grains, meat, fish, egg, dairy products). Furthermore, the booklet includes information and instructions on food related symptoms and atopic eczema. Babies with mild symptoms are encouraged to continue the symptom-eliciting food. All families fill out monthly internet-based questionnaires on food diary, symptoms, diagnoses and health care visits until the age of 1 year.
Interventions
OTHEREarly introduction of solid foods
Early introduction of solid foods
Sponsors
University of Oulu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Months
Healthy volunteers
Yes
Inclusion criteria
* All newborn babies attending local Child Health Clinics
Exclusion criteria
* Parents unable to communicate with Finnish language (questionnaires in Finnish)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of patients with dietary restrictions due to food related symptoms | By the age of one year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of children with parent-reported food allergies | By the age of one year | — |
| The number of children with doctor-diagnosed atopic eczema | By the age of one year | — |
| The number of children with doctor-diagnosed food allergies | By the age of one year | — |
| The number of health care contacts due to food related symptoms | By the age of one year | — |
| Family experienced distress based on questionnaire | By the age of one year | The subjective estimate of the distress (multiple choice scaled questions) related to food induced symptoms in the baby |
| The number of children with parent-reported atopic eczema | By the age of one year | — |
Countries
Finland
Outcome results
None listed