Study on the Induction of Food Tolerance in Babies (INTO)

University of Oulu

Status: Completed

Conditions: Food Hypersensitivity

Treatments: Other: Early introduction of solid foods

Study type: Interventional

Funder types: Other

Identifiers

NCT02825069

Baby-INTO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,214 patients

Sex: All

Ages: Under 1 month old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All newborn babies attending local Child Health Clinics

Exclusion criteria

• Parents unable to communicate with Finnish language (questionnaires in Finnish)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,214 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Other: Early introduction of solid foods

Control group

No Intervention group

Description:

Families are advised to follow the official Finnish Nutrition Recommendations, including exclusive breastfeeding until the age of 6 months.