Food HypersensitivityINTONCT02825069
Study on the Induction of Food Tolerance in Babies
A study testing Early introduction of solid foods in people with Food Hypersensitivity, run by University of Oulu at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages Up to 1 monthHealthy volunteers can take part
- Conditions the study is for
- Food Hypersensitivity
- What is being tested?
- Early introduction of solid foods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,214 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2014to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 month
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All newborn babies attending local Child Health Clinics
Who cannot join
- Parents unable to communicate with Finnish language (questionnaires in Finnish)
Trial locations and contacts
1 site in 1 country.
Finland1 site
PEDEGO Research Unit, University of Oulu and Oulu University Hospital
Oulu, 90014
About this study
Official title: Randomized Controlled 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.
Read the 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.
- Conditions
- Food Hypersensitivity
- Being tested
- Early introduction of solid foods
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early introduction of solid foodsOther
Early introduction of solid foods
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Other: Early introduction of solid foods |
| Control group | No intervention | Families are advised to follow the official Finnish Nutrition Recommendations, including exclusive breastfeeding until the age of 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with dietary restrictions due to food related symptoms
Measured: By the age of one year
Secondary outcomes (6)
The number of children with doctor-diagnosed food allergies
Measured: By the age of one year
The number of children with parent-reported food allergies
Measured: By the age of one year
The number of children with doctor-diagnosed atopic eczema
Measured: By the age of one year
The number of children with parent-reported atopic eczema
Measured: By the age of one year
The number of health care contacts due to food related symptoms
Measured: By the age of one year
Family experienced distress based on questionnaire
The subjective estimate of the distress (multiple choice scaled questions) related to food induced symptoms in the baby
Measured: By the age of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startMar 2014
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food HypersensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,214 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petri Kulmala, University of Oulu
- Investigators
- Petri Kulmala, MD, PhD, Principal investigator, PEDEGO-Research Unit and Medical Research Center Oulu, University of Oulu and Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825069
- Sponsor's protocol ID
- Baby-INTO
- Acronym
- INTO
- Status last verified
- Oct 2017
- First submitted
- 28 Jun 2016
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study on the Induction of Food Tolerance in Babies
- ClinicalTrials.gov ID
- NCT02825069
- Acronym / sponsor ID
- INTO / Baby-INTO
- Conditions
- Food Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,214 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 7 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Early introduction of solid foodsEarly 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. |
| Control group | No intervention | –Families are advised to follow the official Finnish Nutrition Recommendations, including exclusive breastfeeding until the age of 6 months. |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All newborn babies attending local Child Health Clinics
Key exclusion criteria (1 listed)
- Parents unable to communicate with Finnish language (questionnaires in Finnish)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early introduction of solid foodsEarly introduction of solid foods | Other | Intervention group |
Primary outcome
The number of patients with dietary restrictions due to food related symptoms
Time frame: By the age of one year
6 secondary outcomes
The number of children with doctor-diagnosed food allergies
Time frame: By the age of one year
The number of children with parent-reported food allergies
Time frame: By the age of one year
The number of children with doctor-diagnosed atopic eczema
Time frame: By the age of one year
The number of children with parent-reported atopic eczema
Time frame: By the age of one year
The number of health care contacts due to food related symptoms
Time frame: By the age of one year
Family experienced distress based on questionnaire
Time frame: By the age of one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petri Kulmala, MD, PhD principal investigator
PEDEGO-Research Unit and Medical Research Center Oulu, University of Oulu and Oulu University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early introduction of solid foods in people with Food Hypersensitivity, run by University of Oulu at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients with dietary restrictions due to food related symptoms (time frame: By the age of one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.