Study Stopped
difficult to enrol and as a pilot study sample size was not powered anyway
Tolerance of Cereals for Atopic Children
Assessment of Tolerance of Cereals in Infants With Atopic Symptoms
1 other identifier
interventional
45
1 country
1
Brief Summary
In this study, non allergenic cereals will be tested in infants with atopic symptoms. The test will be performed in a hospital.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2009
CompletedFirst Posted
Study publicly available on registry
December 9, 2009
CompletedStudy Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedJune 27, 2012
June 1, 2012
1.9 years
December 8, 2009
June 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Documentation of atopic symptoms and clinical examination for presence or absence of some objective and subjective symptoms with evaluation of severity (SCORAD) if necessary
48 hours
Secondary Outcomes (1)
Morbidity will be assessed by the frequency of adverse events
48 hours
Study Arms (2)
complete non allergenic cereals
ACTIVE COMPARATORexisting commercialized product
complete non allergenic cereals plus
EXPERIMENTALcommercialised product with the addition of a novel ingredient
Interventions
complete cereals suitable for the weaning period
complete cereals suitable for weaning period
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kinderarzt-Allergologie-Sportmedizin Fachklinik Gaißach
Gaißach Bei Bad Tölz, 83674, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2009
First Posted
December 9, 2009
Study Start
February 1, 2010
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
June 27, 2012
Record last verified: 2012-06