GOAt Milk Formula-based Ladder Versus Cow's Milk Ladder

Summary

Children with immunoglobulin E (IgE)-mediated cow's milk allergy (CMA) who react to small amounts of baked cow's milk may require prolonged elimination. Preliminary observations suggest that some may tolerate products prepared with a low-αs1-casein goat milk formula. This study will compare a four-step goat milk formula-based ladder (4-GMFL) with a four-step cow's milk ladder (4-CML).

This exploratory open-label, multicentre, randomised trial will enroll 92 children aged 1-5 years with IgE-mediated CMA, allocated 1:1 to the 4-GMFL or 4-CML group. Both ladders comprise muffin, pancake and baked hard cheese, introduced at 4-week intervals and assessed by open, physician-supervised oral food challenges (OFCs) in hospital, followed by a final OFC with 120 mL of non-heated pasteurised cow's milk at week 12.

The primary outcome will be tolerance to non-heated cow's milk protein at this final step, defined as a negative OFC with 120 mL of pasteurised cow's milk containing 3.96 g of protein. Secondary outcomes will include tolerance to individual ladder products, allergic reactions, anaphylaxis, intramuscular adrenaline use, anthropometric changes, food allergy-related quality of life, caregiver anxiety and adherence. Molecular sensitisation profiles will be explored as potential predictors of OFC outcomes.

Conditions

• Food Allergy
• Cow's Milk Protein Allergy
• Cow's Milk Allergy

Interventions

OTHER

oral food challenge (OFC)

oral food challenges with subsequent steps of a 4-step goat milk formula-based ladder (muffin prepared with goat milk formula, pancake prepared with goat milk formula, baked goat hard cheese, pasteurised cow's milk)

OTHER

oral food challenge (OFC)

oral food challenges with subsequent steps of a 4-step cow's milk ladder (muffin prepared with cow's milk, pancake prepared with cow's milk, baked cow's milk hard cheese, pasteurised cow's milk)

Sponsors & Collaborators

• Medical University of Lublin

  collaborator OTHER

• NYU Langone Health

  collaborator OTHER

• University of Warmia and Mazury in Olsztyn

  collaborator OTHER

• Medical University of Lodz

  collaborator OTHER

• Medical University of Warsaw

  lead OTHER

Principal Investigators

• Hanna Szajewska, MD, Professor · Medical University of Warsaw

• Anna Nowak-Węgrzyn, MD, Professor · Collegium Medicum, University of Warmia and Mazury, Olsztyn, Poland; New York Univeristy, Grossmann School of Medicine

• Andrea Horvath, MD, Professor · Medical Univeristy of Warsaw

• Joanna Jerzyńska, MD, PhD · Medical Univeristy of Lodz

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

5 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2027-01-02

Primary Completion

2030-01-02

Completion

2030-01-02

Countries

• Poland

Study Locations