AllergyNCT01029184
Tolerance of Cereals for Atopic Children
A study testing commercialized complete cereals and commercialized complete cereals with additional ingredient in people with Allergy, run by Société des Produits Nestlé (SPN) at 1 site in Germany.
Trial summary
In this study, non allergenic cereals will be tested in infants with atopic symptoms. The test will be performed in a hospital. Read more about this study
- Who is it for?
- Ages 4 months to 4 years
- Conditions the study is for
- Allergy
- What is being tested?
- commercialized complete cereals and commercialized complete cereals with additional ingredient
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2010to Jan 2012
- 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 4 months to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infant aged from 4 to 40 months at the time of enrolment
- With atopic symptoms and/or positive Skin Prick Test (SPT) or positive specific RAST-IgE or positive Patch Test
- Infants who received a specific elimination oligoallergenic diet from the study site for at least 5 days before the day of enrolment
- Having obtained his/her signed legal representative's informed consent
Who cannot join
- Infant on systemic drugs (e.g. antihistamines) according to half-life at time of enrolment
- Congenital illness or malformation that may affect normal growth (especially immunodeficiency)
- Infant whose parents / caregivers cannot be expected to comply with treatment.
- Infant currently participating in another interventional clinical trial
Trial locations and contacts
1 site in 1 country.
Germany1 site
Kinderarzt-Allergologie-Sportmedizin Fachklinik Gaißach
Gaißach Bei Bad Tölz, 83674
About this study
Official title: Assessment of Tolerance of Cereals in Infants With Atopic Symptoms
In this study, non allergenic cereals will be tested in infants with atopic symptoms. The test will be performed in a hospital.
Read the detailed description
In the majority of food allergy cases, an exclusion diet results in regression of clinical symptoms but this diet may not be nutritionally complete. To feed a baby who has a food allergy, we want a food with low allergenic ingredients.
For this reason, a complete cereal has been specially developed and formulated for the weaning period of infants and young children suffering from milk, soy or wheat protein allergy or hypersensitivity due to celiac disease.
It allows a smooth transition into and through the weaning period. The ingredients of this product are all from vegetable sources and it is therefore suitable for a vegetarian diet. It has been commercialised for many years and has proved to be completely safe, however so far no study has been specifically designed and powered to assess tolerance of this product in infants with atopic symptoms.
In this study we are testing the tolerance (symptoms stability) of non allergenic cereals during an open allergenic test in infants with atopic symptoms and/or positive Skin Prick Test (SPT) or positive specific RAST-IgE or positive Patch Test. We are also testing the same product containing an additional ingredient with a potential effect in allergy management.
Such complete cereals is a very good option for allergic children in comparison to an exclusion diet that may not be nutritionally complete.
- Conditions
- Allergy
- Being tested
- commercialized complete cereals, commercialized complete cereals with additional ingredient
- Keywords
- weaning, cereals, allergy, atopy, open allergenic test
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
commercialized complete cerealsOther
complete cereals suitable for the weaning period
commercialized complete cereals with additional ingredientOther
complete cereals suitable for weaning period
| Study group | Role | What they receive |
|---|---|---|
| complete non allergenic cereals | Active comparator | existing commercialized product Receives: Other: commercialized complete cereals |
| complete non allergenic cereals plus | Experimental | commercialised product with the addition of a novel ingredient Receives: Other: commercialized complete cereals with additional ingredient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Documentation of atopic symptoms and clinical examination for presence or absence of some objective and subjective symptoms with evaluation of severity (SCORAD) if necessary
Measured: 48 hours
Secondary outcomes (1)
Morbidity will be assessed by the frequency of adverse events
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startFeb 2010
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: difficult to enrol and as a pilot study sample size was not powered anyway
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01029184
- Sponsor's protocol ID
- 07.47.INF
- Status last verified
- Jun 2012
- First submitted
- 8 Dec 2009
- Last updated
- 27 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Tolerance of Cereals in Infants With Atopic Symptoms
- ClinicalTrials.gov ID
- NCT01029184
- Acronym / sponsor ID
- 07.47.INF
- Conditions
- Allergy
- Keywords
- weaning, cereals, allergy, atopy, open allergenic test
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficult to enrol and as a pilot study sample size was not powered anyway
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 9 Dec 2009 (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.
In this study, non allergenic cereals will be tested in infants with atopic symptoms. The test will be performed in a hospital.
Detailed description
In the majority of food allergy cases, an exclusion diet results in regression of clinical symptoms but this diet may not be nutritionally complete. To feed a baby who has a food allergy, we want a food with low allergenic ingredients.
For this reason, a complete cereal has been specially developed and formulated for the weaning period of infants and young children suffering from milk, soy or wheat protein allergy or hypersensitivity due to celiac disease.
It allows a smooth transition into and through the weaning period. The ingredients of this product are all from vegetable sources and it is therefore suitable for a vegetarian diet. It has been commercialised for many years and has proved to be completely safe, however so far no study has been specifically designed and powered to assess tolerance of this product in infants with atopic symptoms.
In this study we are testing the tolerance (symptoms stability) of non allergenic cereals during an open allergenic test in infants with atopic symptoms and/or positive Skin Prick Test (SPT) or positive specific RAST-IgE or positive Patch Test. We are also testing the same product containing an additional ingredient with a potential effect in allergy management.
Such complete cereals is a very good option for allergic children in comparison to an exclusion diet that may not be nutritionally complete.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| complete non allergenic cereals | Active comparator | Other: commercialized complete cerealsexisting commercialized product |
| complete non allergenic cereals plus | Experimental | Other: commercialized complete cereals with additional ingredientcommercialised product with the addition of a novel ingredient |
Who may qualify
- Ages
- 4 months to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infant aged from 4 to 40 months at the time of enrolment
- With atopic symptoms and/or positive Skin Prick Test (SPT) or positive specific RAST-IgE or positive Patch Test
- Infants who received a specific elimination oligoallergenic diet from the study site for at least 5 days before the day of enrolment
- Having obtained his/her signed legal representative's informed consent
Key exclusion criteria (4 listed)
- Infant on systemic drugs (e.g. antihistamines) according to half-life at time of enrolment
- Congenital illness or malformation that may affect normal growth (especially immunodeficiency)
- Infant whose parents / caregivers cannot be expected to comply with treatment.
- Infant currently participating in another interventional clinical trial
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 |
|---|---|---|
| commercialized complete cerealscomplete cereals suitable for the weaning period | Other | complete non allergenic cereals |
| commercialized complete cereals with additional ingredientcomplete cereals suitable for weaning period | Other | complete non allergenic cereals plus |
Primary outcome
Documentation of atopic symptoms and clinical examination for presence or absence of some objective and subjective symptoms with evaluation of severity (SCORAD) if necessary
Time frame: 48 hours
1 secondary outcome
Morbidity will be assessed by the frequency of adverse events
Time frame: 48 hours
Results and safety
The study was stopped early (reason given: difficult to enrol and as a pilot study sample size was not powered anyway). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing commercialized complete cereals and commercialized complete cereals with additional ingredient in people with Allergy, run by Société des Produits Nestlé (SPN) at 1 site in Germany.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 27 Jun 2012. 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 Germany. 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 was stopped early (reason given: difficult to enrol and as a pilot study sample size was not powered anyway). Results are not available in the source record.
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?
Documentation of atopic symptoms and clinical examination for presence or absence of some objective and subjective symptoms with evaluation of severity (SCORAD) if necessary (time frame: 48 hours). 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 Jun 2012.