|- candidate number||5250|
|- NTR Number||NTR1654|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-feb-2009|
|- Secondary IDs||CMA.1.C/A/0 |
|- Public Title||Hypoallergenicity of an extensively hydrolyzed whey protein infant formula in children with cow's milk allergy.|
|- Scientific Title||Hypoallergenicity of an extensively hydrolyzed whey protein infant formula in children with cow's milk allergy.|
|- hypothesis||The formula will be tolerated by at least 90% of the children with cow's milk allergy with a confidence interval of 95%. |
|- Healt Condition(s) or Problem(s) studied||Cow's milk allergy|
|- Inclusion criteria||1. Children with cow's milk allergy, diagnosed by a double-blind, placebo-controlled food challenge (DBPCFC) within 4 weeks prior to study start;|
2. Aged from birth to 24 months;
3. Expected daily intake of at least 500ml of the study product during phase B;
4. Written informed consent of both parents/caretakers.
|- Exclusion criteria||1. Children consuming mother's milk at the time of inclusion and during the trial;|
2. Intolerance for lactose or any other component of the study product(s);
3. History of anaphylactic reaction, including severe cardiovascular symptoms (shock), severe laryngeal edema, and bronchus obstruction;
4. History of cardiovascular, gastrointestinal, hepatic, renal or respiratory chronic disease other than allergy;
5. Major congenital abnormalities;
6. Inability to adhere to protocol. instructions.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||20-feb-2009|
|- planned closingdate||31-dec-2009|
|- Target number of participants||47|
|- Interventions||Duration of intervention: |
Phase A: one day, twice;
Phase B: two weeks.
Intervention group: extensively hydrolyzed whey protein based infant formula.
Control group: amio acid-based infant formula.
|- Primary outcome||Phase A: immediate and delayed allergic reactions to DBPCFC with the extensively hydrolyzed whey protein-based infant formula; |
Phase B: gastro-intestinal tolerability and allergic symptoms.
|- Secondary outcome||Phase A: none; |
Phase B: product convenience.
|- Timepoints||Screening will take at least one hospital visit. As from the start of phase A, the study will take 3 hospital visits and 3 phone calls.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||PhD M. Roelofs|
|- CONTACT for SCIENTIFIC QUERIES|| L. Dumon|
|- Sponsor/Initiator ||Danone Research B.V.|
(Source(s) of Monetary or Material Support)
|Danone Research B.V. |
|- Brief summary||Cow’s milk allergy is caused by an abnormal reaction of a child’s immune system to milk proteins and is characterized by rapid appearance of symptoms, such as wheezing, vomiting, diarrhea, abdominal pain, and exacerbation of eczema, after consumption of cow’s milk proteins.
Treatment of cow’s milk allergy in children therefore means total avoidance of cow’s milk and use of special developed so−called ‘hypoallergenic’ milk formulas. In the ‘hypoallergenic' milk formulas the milk proteins are broken down into small pieces, so the immune system does not recognize the proteins as dangerous anymore and no allergic reaction is provoked.
Even hypoallergenic formulas might contain some cow’s milk proteins that were not broken down sufficiently. The remaining bigger proteins might still provoke allergic reactions in children with cow’s milk allergy. Therefore hypoallergenic formulas first need to be tested in research studies before they can be generally used to treat children with cow’s milk allergy. Such studies must demonstrate that the formula is tolerated by a substantial percentage of children with cow’s milk allergy and does not cause allergic responses.
In the current study a new hypoallergenic milk formula will be tested in children aged 0 to 24 months with cow's milk allergy. For the participants, the study will last a minimum of 6 weeks and consists of several hospital visits and assessments, including a double−blind, placebo−controlled food challenge. Furthermore, the participant's parents should complete diaries regarding their child's food intake (including study product) and gastro−intestinal/allergic symptoms.
|- Main changes (audit trail)|
|- RECORD||2-feb-2009 - 30-okt-2010|