Study on the Induction of Food Tolerance in Babies

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Controlled Study on the Induction of Food Tolerance in Babies

Conditions
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Food Hypersensitivity

Intervention / Treatment
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* Other: Early introduction of solid foods


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All newborn babies attending local Child Health Clinics Exclusion Criteria: Parents unable to communicate with Finnish language (questionnaires in Finnish)

Ages Eligible for Study
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Maximum Age: 1 Month

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Early 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). Babies presenting with mild symptoms are encouraged to continue the symptom-eliciting food. | Other: Early introduction of solid foods<br>* Early introduction of solid foods<br>|
| No Intervention: Control group<br>Families are advised to follow the official Finnish Nutrition Recommendations, including exclusive breastfeeding until the age of 6 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients with dietary restrictions due to food related symptoms |  | By the age of one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of children with doctor-diagnosed food allergies |  | By the age of one year | 
| 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 parent-reported atopic eczema |  | 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 | The subjective estimate of the distress (multiple choice scaled questions) related to food induced symptoms in the baby | By the age of one year |