Evaluation of Tolerance, Efficacy and Safety of an Hydrolyzed Formula in Infants With IgE/Non-IgE Mediated CMA. (MERLIN)

United Pharmaceuticals

Status: Active, not recruiting

Conditions: Cow's Milk Allergy

Treatments: Dietary Supplement: Placebo Formula; Dietary Supplement: Test Formula

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06481280

UP2022-01-MERLIN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 1 to 24 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 (>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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

Test Formula

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Test Formula

Dietary Supplement: Placebo Formula

Placebo Formula

Placebo Comparator group

Description:

Infants will receive a placebo formula (=their previous formula) during the DBPCFC to compare against the test formula.

Treatment:

Dietary Supplement: Test Formula

Dietary Supplement: Placebo Formula