The aim of this interventional study is to assess the hypoallergenicity of a new formula in infants having a cow milk allergy (CMA), whatever the type of CMA, meaning in both IgE-mediated and non-IgE-mediated CMA patients. This will be tested through a double-blind placebo controlled food challenge (DBPCFC) taking place over 2 or 3 separate days, in hospital. If the child tolerates the tested formula during the DBPCFC, he will be fed with the test formula during the second study phase. There will be monthly visit and parents will be asked to fill in diaries.
Briefly, on two separate days, the placebo formula and the TEHCF will be introduced at increasing doses under medical supervision, and appearance of allergic symptoms will be witnessed and recorded if any. The week after, and more particularly the 72 hours after each food challenge day, child's parents will be instructed to report to the investigator any delayed reaction that may occur. In case the TEHCF induces an allergic reaction, the child's participation will be ended. Otherwise, the child will enter the second study part, lasting 4 months and during which the usual formula taken by the child will be totally replaced by the TEHCF.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
70
Infants will receive an extensively hydrolyzed formula during the double-blind placebo-controlled food challenge (DBPCFC) and will continue on this formula during the open-label feeding phase if they tolerate it.
Infants will receive a placebo formula during the DBPCFC to compare against the test formula.
Private practice Elena BRADATAN
Namur, Begium, Belgium
University Hospital - Umberto I Sapienza
Roma, Italy
Hypoallergenicity of the formula
the percentage of children tolerating the formula during the double blind placebo controlled food challenge
Time frame: 7 days
Cow's Milk Related Symptom Score (CoMiSS™)
The Cow's Milk Related Symptom Score (CoMiSS™) will be evaluated globally and each of its subscore. CoMiSS ranges from 0 to 33 (worst outcome).
Time frame: At each visit : day7, day 30, day 60, day 90 and day 120
Atopic dermatitis severity - SCORing Atopic Dermatitis (SCORAD) Index
Atopic dermatitis is assessed using the SCORing Atopic Dermatitis (SCORAD) Index. The score ranges from 0 to 103 (most severe state) and is used to determine the stages of severity of AD.
Time frame: At each visit : day7, day 30, day 60, day 90 and day 120
Gastrointestinal CMA symptoms
the other Gastrointestinal CMA symptoms (not described by the COMISS) will be reported (such as acute diarrhea, constipation...)
Time frame: At each visit : day7, day 30, day 60, day 90 and day 120
Cutaneous CMA symptoms
Others Cutaneous CMA symptoms besides those evaluated in the CoMISS and the SCORAD will be described
Time frame: At each visit : day7, day 30, day 60, day 90 and day 120
Sleep characteristics
This measures focuses on evaluating the quality and duration of sleep in children consuming the test.
Time frame: At each visit : day7, day 30, day 60, day 90 and day 120
Weight
Weight will be expressed in kg and in z scores according to the World Health Organization (WHO) Child Growth Standards.
Time frame: At each monthly visit day 30, day 60, day 90 and day 120
Height
Height will be expressed in cm and in z scores according to the WHO Child Growth Standards.
Time frame: At each monthly visit day 30, day 60, day 90 and day 120
Head circumference
Head circumference will be expressed in cm and in z scores according to the WHO Child Growth Standards.
Time frame: At each monthly visit day 30, day 60, day 90 and day 120
BMI
BMI will be expressed in value and z scores according to the WHO Child Growth Standards.
Time frame: At each monthly visit day 30, day 60, day 90 and day 120
Adverse event
Any untoward medical reaction occuring from the signatture of the consent until the end of the participant's participation
Time frame: During the whole study duration
Compliance
It will be assessed through the volume of formula consumed
Time frame: At each visit : day7, day 30, day 60, day 90 and day 120
Parents' satisfaction
Satisfaction regarding the effect of the study formula on regurgitations, stool consistency, digestive comfort, and the acceptability of the formula by the child will be evaluated by using a 5-level satisfaction scale (very satisfied/satisfied/unsatisfied/very unsatisfied / without opinion)
Time frame: At each visit : day7, day 30, day 60, day 90 and day 120
Investigator's satisfaction
paediatrician's satisfaction with the effect of the study formula on the child) will be assessed by using a 4-level satisfaction scale (very satisfied/satisfied/unsatisfied/very unsatisfied).
Time frame: At each visit : day7, day 30, day 60, day 90 and day 120
Digestive tolerance
Digestive tolerance of the formula will be assessed by monitoring stool frequency and consistency, regurgitations, abdominal pain/painful flatus/ bloating, crying time, irritability time.
Time frame: At each visit : day7, day 30, day 60, day 90 and day 120
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