Evaluation of Tolerance, Efficacy and Safety of an Hydrolyzed Formula in Infants With IgE/Non-IgE Mediated CMA.
NCT Number: NCT06481280
Acronym: MERLIN
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cow's Milk Allergy
Interventions: DIETARY_SUPPLEMENT: Test Formula|DIETARY_SUPPLEMENT: Placebo Formula
Sponsor: United Pharmaceuticals
Collaborators: Slb Pharma
Sex: ALL
Age: CHILD
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-07
Completion Date: 2026-06
Locations: Private practice Elena BRADATAN, Namur, Begium, 5000, Belgium|University Hospital - Umberto I Sapienza, Roma, 00161, Italy

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.

Primary Outcome Measures: Hypoallergenicity of the formula, the percentage of children tolerating the formula during the double blind placebo controlled food challenge, 7 days
Secondary Outcome Measures: 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)., 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., 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...), 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, 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., 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., 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., 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., 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., 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, During the whole study duration|Compliance, It will be assessed through the volume of formula consumed, 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), 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)., 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., At each visit : day7, day 30, day 60, day 90 and day 120