Active — Not RecruitingNot Applicable

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

Belgium, Italy70 participantsStarted 2024-08-14

Plain-language 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.

Who can participate

Age range1 Month – 24 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 (\&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

What they're measuring

Hypoallergenicity of the formula

Timeframe: 7 days

Trial details

NCT IDNCT06481280

SponsorUnited Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01