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

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ClinicalTrials.gov Identifier: NCT02825069
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
Petri Kulmala, University of Oulu

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.

Condition or disease Intervention/treatment Phase
Food Hypersensitivity Other: Early introduction of solid foods Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Controlled Study on the Induction of Food Tolerance in Babies
Actual Study Start Date : March 2014
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. The number of patients with dietary restrictions due to food related symptoms [ Time Frame: By the age of one year ]

Secondary Outcome Measures :
  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



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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All newborn babies attending local Child Health Clinics

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825069


Locations
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Finland
PEDEGO Research Unit, University of Oulu and Oulu University Hospital
Oulu, Finland, 90014
Sponsors and Collaborators
University of Oulu
Investigators
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Principal Investigator: Petri Kulmala, MD, PhD PEDEGO-Research Unit and Medical Research Center Oulu, University of Oulu and Oulu University Hospital

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Responsible Party: Petri Kulmala, MD, PhD, Clinical lecturer, University of Oulu
ClinicalTrials.gov Identifier: NCT02825069     History of Changes
Other Study ID Numbers: Baby-INTO
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate