Tolerance of Cereals for Atopic Children

This study has been terminated.
(difficult to enrol and as a pilot study sample size was not powered anyway)
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01029184
First received: December 8, 2009
Last updated: June 26, 2012
Last verified: June 2012
  Purpose

In this study, non allergenic cereals will be tested in infants with atopic symptoms. The test will be performed in a hospital.


Condition Intervention
Allergy
Other: commercialized complete cereals
Other: commercialized complete cereals with additional ingredient

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of Tolerance of Cereals in Infants With Atopic Symptoms

Resource links provided by NLM:


Further study details as provided by Nestlé:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Morbidity will be assessed by the frequency of adverse events [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Enrollment: 45
Study Start Date: February 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: complete non allergenic cereals
existing commercialized product
Other: commercialized complete cereals
complete cereals suitable for the weaning period
Experimental: complete non allergenic cereals plus
commercialised product with the addition of a novel ingredient
Other: commercialized complete cereals with additional ingredient
complete cereals suitable for weaning period

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.

  Eligibility

Ages Eligible for Study:   4 Months to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01029184

Locations
Germany
Kinderarzt-Allergologie-Sportmedizin Fachklinik Gaißach
Gaißach bei Bad Tölz, Germany, 83674
Sponsors and Collaborators
Nestlé
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01029184     History of Changes
Other Study ID Numbers: 07.47.INF
Study First Received: December 8, 2009
Last Updated: June 26, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Nestlé:
weaning
cereals
allergy
atopy
open allergenic test

ClinicalTrials.gov processed this record on September 18, 2014