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Completed

NCT Number: NCT02825069

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.

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Key information

Conditions

Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

Up to 1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PEDEGO Research Unit, University of Oulu and Oulu University Hospital

Oulu, 90014, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All newborn babies attending local Child Health Clinics

Exclusion criteria

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

Treatment and study plan

Early introduction of solid foods

Other

Early introduction of solid foods

Primary outcomes

  1. The number of patients with dietary restrictions due to food related symptoms

    Time frame: By the age of one year

Secondary outcomes

  1. The number of children with doctor-diagnosed food allergies

    Time frame: By the age of one year

  2. The number of children with parent-reported food allergies

    Time frame: By the age of one year

  3. The number of children with doctor-diagnosed atopic eczema

    Time frame: By the age of one year

  4. The number of children with parent-reported atopic eczema

    Time frame: By the age of one year

  5. The number of health care contacts due to food related symptoms

    Time frame: By the age of one year

  6. Family experienced distress based on questionnaire

    Time frame: By the age of one year

    The subjective estimate of the distress (multiple choice scaled questions) related to food induced symptoms in the baby

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Registry information

Official study title

Randomized Controlled Study on the Induction of Food Tolerance in Babies

Acronym: INTO

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 7, 2016
Registry last updated
Oct 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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