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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-14

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cow's Milk Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Masking only applies to the 1st part of the study : during this part all parties (participant, care provide, investigator and outcomes assessor) will be blinded.

The 2nd study part is open-label , there is no masking during this phase

Study Groups

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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.

Group Type EXPERIMENTAL