Study on the Induction of Food Tolerance in Babies

Not Applicable

Completed

• Conditions: Food Hypersensitivity
• Interventions: Other: Early introduction of solid foods

• Registration Number: NCT02825069
• Lead Sponsor: University of Oulu

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.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2016-06-28
• Study First Submitted QC: 2016-07-01
• Study First Posted: 2016-07-07
• Status Verified: 2017-10
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Last Update Submitted: 2017-10-25
• Last Update Posted: 2017-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1214

Inclusion Criteria

• All newborn babies attending local Child Health Clinics

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Early introduction of solid foods	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.

Primary Outcome Measures

Name	Time	Method
The number of patients with dietary restrictions due to food related symptoms	By the age of one year

Secondary Outcome Measures

Name	Time	Method
The number of children with parent-reported 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
The number of children with doctor-diagnosed 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
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

Trial Locations

Locations (1)

PEDEGO Research Unit, University of Oulu and Oulu University Hospital; 🇫🇮 Oulu, Finland