Evaluation of Tolerance, Efficacy and Safety of an Hydrolyzed Formula in Infants With IgE/Non-IgE Mediated CMA.
- Conditions
- Cow's Milk Allergy
- Interventions
- Dietary Supplement: Test FormulaDietary Supplement: Placebo Formula
- Registration Number
- NCT06481280
- Lead Sponsor
- United Pharmaceuticals
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 70
- between 1 and 24 months old
- having a CMA proven in the last 3 months prior to inclusion
- free of clinical allergic symptoms for at least one week (i.e., successfully fed an elimination diet)
- whose parent(s)/legal guardian(s) signed the informed consent form.
Main
-
Children mainly (>1 breastfeeding/day) or exclusively breastfed, with maternal willingness to continue breast-feeding
-
Children with a mean formula intake lower than 250 ml/day
-
Children with past anaphylactic reaction(s)
-
Children with chronic (non acute) FPIES
-- Children presenting with any situation which, according to the investigator, may interfere with the study participation, or lead to a particular risk for the subject,
-
Children already participating in another clinical trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Test Formula Placebo Formula 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. Placebo Formula Test Formula Infants will receive a placebo formula (=their previous formula) during the DBPCFC to compare against the test formula. Test Formula Test Formula 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. Placebo Formula Placebo Formula Infants will receive a placebo formula (=their previous formula) during the DBPCFC to compare against the test formula.
- Primary Outcome Measures
Name Time Method Hypoallergenicity of the formula 7 days the percentage of children tolerating the formula during the double blind placebo controlled food challenge
- Secondary Outcome Measures
Name Time Method Cow's Milk Related Symptom Score (CoMiSS™) At each visit : day7, day 30, day 60, day 90 and day 120 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).
Sleep characteristics At each visit : day7, day 30, day 60, day 90 and day 120 This measures focuses on evaluating the quality and duration of sleep in children consuming the test.
Weight At each monthly visit day 30, day 60, day 90 and day 120 Weight will be expressed in kg and in z scores according to the World Health Organization (WHO) Child Growth Standards.
Height At each monthly visit day 30, day 60, day 90 and day 120 Height will be expressed in cm and in z scores according to the WHO Child Growth Standards.
BMI At each monthly visit day 30, day 60, day 90 and day 120 BMI will be expressed in value and z scores according to the WHO Child Growth Standards.
Compliance At each visit : day7, day 30, day 60, day 90 and day 120 It will be assessed through the volume of formula consumed
Atopic dermatitis severity - SCORing Atopic Dermatitis (SCORAD) Index At each visit : day7, day 30, day 60, day 90 and day 120 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.
Gastrointestinal CMA symptoms At each visit : day7, day 30, day 60, day 90 and day 120 the other Gastrointestinal CMA symptoms (not described by the COMISS) will be reported (such as acute diarrhea, constipation...)
Cutaneous CMA symptoms At each visit : day7, day 30, day 60, day 90 and day 120 Others Cutaneous CMA symptoms besides those evaluated in the CoMISS and the SCORAD will be described
Head circumference At each monthly visit day 30, day 60, day 90 and day 120 Head circumference will be expressed in cm and in z scores according to the WHO Child Growth Standards.
Adverse event During the whole study duration Any untoward medical reaction occuring from the signatture of the consent until the end of the participant's participation
Parents' satisfaction At each visit : day7, day 30, day 60, day 90 and day 120 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)
Investigator's satisfaction At each visit : day7, day 30, day 60, day 90 and day 120 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).
Digestive tolerance At each visit : day7, day 30, day 60, day 90 and day 120 Digestive tolerance of the formula will be assessed by monitoring stool frequency and consistency, regurgitations, abdominal pain/painful flatus/ bloating, crying time, irritability time.
Trial Locations
- Locations (2)
Private practice Elena BRADATAN
🇧🇪Namur, Begium, Belgium
University Hospital - Umberto I Sapienza
🇮🇹Roma, Italy