Clinical trial NCT06481280: Evaluation of Tolerance, Efficacy and Safety of an Hydrolyzed Formula in Infants With IgE/Non-IgE Mediated CMA.
Official title: Cow's Milk Allergy (CMA): Evaluation of Tolerance, Efficacy and Safety of a Thickened Extensively Hydrolyzed Formula in Infants With IgE and Non-IgE Mediated CMA
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cow's Milk Allergy
Keywords: CMA (Cow's Milk Allergy)
DBPCFC (Double-Blind Placebo-Controlled Food Challenge)
FA (Food Allergy)
IgE (Immunoglobulin E)
OFC (Oral Food Challenge)
Lead sponsor: United Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Slb Pharma
First posted: 2024-07-01
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The first part of the study consists in a double-blind placebo-controlled food challenge (DBPCFC) during which all patient will receive the test formula and a placebo, in a randomised order.

During the second part of the study, all patients will be fed the test formula (open-label phase).
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* 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 Exclusion Criteria:

* Children mainly (\&amp;gt;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

Primary outcomes:
measure: Hypoallergenicity of the formula
timeFrame: 7 days
Secondary outcomes:
measure: Cow's Milk Related Symptom Score (CoMiSS™)
timeFrame: At each visit : day7, day 30, day 60, day 90 and day 120
measure: Atopic dermatitis severity - SCORing Atopic Dermatitis (SCORAD) Index
timeFrame: At each visit : day7, day 30, day 60, day 90 and day 120
measure: Gastrointestinal CMA symptoms
timeFrame: At each visit : day7, day 30, day 60, day 90 and day 120
measure: Cutaneous CMA symptoms
timeFrame: At each visit : day7, day 30, day 60, day 90 and day 120
measure: Sleep characteristics
timeFrame: At each visit : day7, day 30, day 60, day 90 and day 120
measure: Weight
timeFrame: At each monthly visit day 30, day 60, day 90 and day 120
measure: Height
timeFrame: At each monthly visit day 30, day 60, day 90 and day 120
measure: Head circumference
timeFrame: At each monthly visit day 30, day 60, day 90 and day 120
measure: BMI
timeFrame: At each monthly visit day 30, day 60, day 90 and day 120
measure: Adverse event
timeFrame: During the whole study duration
measure: Compliance
timeFrame: At each visit : day7, day 30, day 60, day 90 and day 120
measure: Parents' satisfaction
timeFrame: At each visit : day7, day 30, day 60, day 90 and day 120
measure: Investigator's satisfaction
timeFrame: At each visit : day7, day 30, day 60, day 90 and day 120
measure: Digestive tolerance
timeFrame: At each visit : day7, day 30, day 60, day 90 and day 120
Other outcomes:
Locations:
city: Namur
country: Belgium
facility: Private practice Elena BRADATAN
state: Begium
city: Roma
country: Italy
facility: University Hospital - Umberto I Sapienza
Study officials:
affiliation: University Hospital - Umberto I
name: Salvatore OLIVA, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: