Study on the Induction of Food Tolerance in Babies

Food Hypersensitivity Clinical Trial

— INTO  

Official title:

Randomized Controlled Study on the Induction of Food Tolerance in Babies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02825069
• Other study ID #: Baby-INTO
• Status: Completed
• Phase: N/A
• First received: June 28, 2016
• Last updated: October 25, 2017
• Start date: March 2014
• Est. completion date: October 2017

Study information

• Verified date: October 2017
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1214
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 1 Month

Eligibility

Inclusion Criteria:

• All newborn babies attending local Child Health Clinics

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Food Hypersensitivity
• Hypersensitivity

Intervention

Other:
• Early introduction of solid foods
Early introduction of solid foods

Locations

Country	Name	City	State
Finland	PEDEGO Research Unit, University of Oulu and Oulu University Hospital	Oulu

Sponsors (1)

Lead Sponsor	Collaborator
University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of patients with dietary restrictions due to food related symptoms		By the age of one year
Secondary	The number of children with doctor-diagnosed food allergies		By the age of one year
Secondary	The number of children with parent-reported food allergies		By the age of one year
Secondary	The number of children with doctor-diagnosed atopic eczema		By the age of one year
Secondary	The number of children with parent-reported atopic eczema		By the age of one year
Secondary	The number of health care contacts due to food related symptoms		By the age of one year
Secondary	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