Back to resultsStudy on the Induction of Food Tolerance in Babies (INTO)
Primary Purpose
Food Hypersensitivity
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Early introduction of solid foods
Sponsored by
About this trial
This is an interventional prevention trial for Food Hypersensitivity
Eligibility Criteria
Inclusion Criteria:
- All newborn babies attending local Child Health Clinics
Exclusion Criteria:
- Parents unable to communicate with Finnish language (questionnaires in Finnish)
Sites / Locations
- PEDEGO Research Unit, University of Oulu and Oulu University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
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.
Families are advised to follow the official Finnish Nutrition Recommendations, including exclusive breastfeeding until the age of 6 months.
Outcomes
Primary Outcome Measures
The number of patients with dietary restrictions due to food related symptoms
Secondary Outcome Measures
The number of children with doctor-diagnosed food allergies
The number of children with parent-reported food allergies
The number of children with doctor-diagnosed atopic eczema
The number of children with parent-reported atopic eczema
The number of health care contacts due to food related symptoms
Family experienced distress based on questionnaire
The subjective estimate of the distress (multiple choice scaled questions) related to food induced symptoms in the baby
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02825069
Brief Title
Study on the Induction of Food Tolerance in Babies
Acronym
INTO
Official Title
Randomized Controlled Study on the Induction of Food Tolerance in Babies
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 2014 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oulu
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Hypersensitivity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1214 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Families are advised to follow the official Finnish Nutrition Recommendations, including exclusive breastfeeding until the age of 6 months.
Intervention Type
Other
Intervention Name(s)
Early introduction of solid foods
Intervention Description
Early introduction of solid foods
Primary Outcome Measure Information:
Title
The number of patients with dietary restrictions due to food related symptoms
Time Frame
By the age of one year
Secondary Outcome Measure Information:
Title
The number of children with doctor-diagnosed food allergies
Time Frame
By the age of one year
Title
The number of children with parent-reported food allergies
Time Frame
By the age of one year
Title
The number of children with doctor-diagnosed atopic eczema
Time Frame
By the age of one year
Title
The number of children with parent-reported atopic eczema
Time Frame
By the age of one year
Title
The number of health care contacts due to food related symptoms
Time Frame
By the age of one year
Title
Family experienced distress based on questionnaire
Description
The subjective estimate of the distress (multiple choice scaled questions) related to food induced symptoms in the baby
Time Frame
By the age of one year
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All newborn babies attending local Child Health Clinics
Exclusion Criteria:
Parents unable to communicate with Finnish language (questionnaires in Finnish)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petri Kulmala, MD, PhD
Organizational Affiliation
PEDEGO-Research Unit and Medical Research Center Oulu, University of Oulu and Oulu University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
PEDEGO Research Unit, University of Oulu and Oulu University Hospital
City
Oulu
ZIP/Postal Code
90014
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
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Study on the Induction of Food Tolerance in Babies
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