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

Randomized Controlled Study on the Induction of Food Tolerance in Babies

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.

Study Overview

• Status: Completed
• Conditions: Food Hypersensitivity
• Intervention / Treatment: Other: Early introduction of solid foods

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 Type: Interventional
• Enrollment (Actual): 1214
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Oulu, Finland, 90014
    • PEDEGO Research Unit, University of Oulu and Oulu University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 month (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All newborn babies attending local Child Health Clinics

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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; Early introduction of solid foods
No Intervention: Control group; Families are advised to follow the official Finnish Nutrition Recommendations, including exclusive breastfeeding until the age of 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Oulu
• Investigators: Principal Investigator: Petri Kulmala, MD, PhD, PEDEGO-Research Unit and Medical Research Center Oulu, University of Oulu and Oulu University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: June 28, 2016
• First Submitted That Met QC Criteria: July 1, 2016
• First Posted (Estimate): July 7, 2016

Study Record Updates

• Last Update Posted (Actual): October 27, 2017
• Last Update Submitted That Met QC Criteria: October 25, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: Baby-INTO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO