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Study on the Induction of Food Tolerance in Babies

NCT ID: NCT02825069

Last Updated: 2017-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2017-10-31

Brief Summary

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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

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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.

Conditions

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Food Hypersensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Early introduction of solid foods

Intervention Type OTHER

Early introduction of solid foods

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Early introduction of solid foods

Early introduction of solid foods

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All newborn babies attending local Child Health Clinics

Exclusion Criteria

* Parents unable to communicate with Finnish language (questionnaires in Finnish)
Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Oulu

OTHER

Sponsor Role lead

Responsible Party

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Petri Kulmala

MD, PhD, Clinical lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Petri Kulmala, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

PEDEGO-Research Unit and Medical Research Center Oulu, University of Oulu and Oulu University Hospital

Locations

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PEDEGO Research Unit, University of Oulu and Oulu University Hospital

Oulu, , Finland

Site Status

Countries

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Finland

Other Identifiers

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Baby-INTO

Identifier Type: -

Identifier Source: org_study_id