The primary study objective is to assess the hypoallergenicity of an extensively hydroloyzed whey protein infant formula in children with cow's milk allergy.The second study objective is to assess the long-term effects on growth and tolerance…
ID
Source
Brief title
Condition
- Allergic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Incidence of immediate and/or delayed allergic reactions.
Secondary outcome
Anthropometrics, gastro-intestinal tolerability and faecal characteristics.
Blood safety and tolerance parameters.
Background summary
Nutricia Research recently developed an upgrade to their existing extensively
hydrolyzed formula, based on an extensively hydrolyzed whey proteins. The
formula has been enriched.
The recently developed new formula has a peptide distribution of all peptides
in size below 3000 Dalton. Althought the American Academy of Pediatrics (AAP)
defines an extensively hydrolyzed formula as a formula that contains only
peptides that have a molecular weight of less than 3000 Dalton, there is no
clear evidence that such a threshold would ensure to prevent from provoking
allergic reactions in infants and young children with cow's milk allergy.
Therefore, after appropriate preclinical testing, hypoallergenic formulas must
demontstrate in clinical studies that with 95% confidence they do not provoke
allergic reactions in 90% of infants or children with confirmed cow's milk
allergy.
Study objective
The primary study objective is to assess the hypoallergenicity of an
extensively hydroloyzed whey protein infant formula in children with cow's milk
allergy.
The second study objective is to assess the long-term effects on growth and
tolerance of an extensively hydrolyzed whey protein infant formula in children
with cow's milk allergy.
Study design
This is a prospective, controlled, multi-country study. Phase A includes a
DBPCFC (double blind placebo controlled food challenge) which involves a
crossover procedure. Additionally phase A includes an open challenge with a
single-arm design. Phase B is optional and designed as an open-label,
single-arm study.
Intervention
Test procuct: the upgrade of an extenstensively hydrolized formula based on
extensively hydrolyzed whey proteins.
Reference product: Neocate.
Patients will take both products, each on one of the two Provocation test days.
Next to that the test product will be taken open label during one week.
If a patient participates in fase B, the testproduct will be taken open label
during 16 weeks.
Study burden and risks
DBFCs, which are performed during this study, are considered as the 'gold
standard' for the diagnosis of food allergies for over 20 years. In this study
DBPCFCs are performed in specialized centres by experienced staff according to
controlled procedures; adverse reactions, such as eczema, asthmatic symptoms
and urticaria, to DBPCFCs could occur.
Children with a history of anaphylactic reactions will be excluded for
participation.
The blood samples during this study are collected by appropriately trained
staff. This may be slightly painful to the subject and may induce some local
bruising. Anesthetic cream will be applied to the skin before taking the blood
sample.
Measurements taken to treat any unexpected severe allergic reactions
adequately, i.e. anafylactische shock is described in Appendix III, #3 of the
protocol: Intramuscular adrenaline, inhaled bronchodilator, oral or intravenous
antihistamine, orale of intravenous corticosteroids should be available during
DBPCFC, for immediate use. According to standard medical care and procedures.
Uppsalalaan 12
Utrecht 3584 CT
NL
Uppsalalaan 12
Utrecht 3584 CT
NL
Listed location countries
Age
Inclusion criteria
- Children with a documented cow's milk allergy.
- Between birth and 3 years of age.
- Expected daily intake of at least 250ml of the study product during the open challenge.
Exclusion criteria
- Children who receive breastfeeding more than twice daily during the week before inclusion.
- Confirmed history of anaphylactic reaction, including severe cardiovascular symptoms, severe laryngeal edema, and bronchus obstruction.
- Intolerance for lactose or any other component of the study product(s).
- Previous signs of allergy to any extensively hydrolyzed formula.
- Previous use of an amino acid formula due to (suspected) severe cow's milk allergy.
- Major congenital malformations.
-Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL41090.075.12 |
| OMON | NL-OMON21357 |