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

NCT07795957 | Not Yet Recruiting DMC

• 1 other identifier: GOAL2026
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

IgE-mediated cow's milk allergy; children; milk ladder; goat milk formula

Outcome Measures

Primary Outcomes (1)

• Between-group difference in the proportion of children who tolerate non-heated pasteurised cow's milk

  The primary outcome will be the between-group difference in the proportion of children who tolerate non-heated pasteurised cow's milk. Tolerance will be defined as the absence of an allergic reaction during an OFC with 120 mL of pasteurised cow's milk, corresponding to 3.96 g of cow's milk protein. In both the 4-CML and 4-GMFL groups, this OFC constitutes Step 4 and the final step of the ladder.

  Non-heated pasteurised cow's milk will be administered at the end of the observation period (week 12).

Secondary Outcomes (9)

• Between-group difference in the proportion of children tolerating the full predefined dose at Steps 1-3

  Baseline (Step 1), week 4 (Step 2) and week 8 (Step 3)

• Between-group difference in maximum tolerated dose at each ladder step

  Baseline (Step 1), week 4 (Step 2) and week 8 (Step 3)

• Between-group difference in the percentage of children who experienced anaphylaxis

  Measured during the observation period (12 weeks).

• Between-group difference in the proportion of children with anaphylaxis (grades 3-5, per 2023 WAO criteria) who required epinephrine administration

  Measured during the observation period (12 weeks).

• Between-group differences in anthropometric changes

  Measured during the observation period (12 weeks).

Study Arms (2)

4-step Goat Milk Formula-Based Ladder

EXPERIMENTAL

Other: oral food challenge (OFC)

4-step Cow's Milk Ladder

ACTIVE COMPARATOR

Other: oral food challenge (OFC)

Interventions

oral food challenge (OFC) OTHER

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)

4-step Goat Milk Formula-Based Ladder

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age between 1 and 5 years.
• Diagnosis of IgE-mediated CMA confirmed according to ESPGHAN guidelines, by a positive OFC with CMPs. In high-risk children (i.e., with a history of anaphylaxis occurring more than 6 months before enrolment) diagnosis may be established without a new OFC, based on a positive SPT wheal at least 3 mm greater than negative saline control and elevated specific IgE to CMPs \>0.35 kUa/L.
• On a cow's milk-free, therapeutic elimination diet for at least 6 months, or since before 12 months of age.
• Eligible regardless of the risk of systemic reaction (anaphylaxis) and asthma.
• Overall good health status.
• Parents/legal guardians able to understand the study procedures and communicate effectively with the study team.
• Written informed consent provided by parents/legal guardians.
• Expected good cooperation of the child's parents/legal guardians with the study team.

You may not qualify if:

• Uncontrolled asthma, defined as poor control according to the current GINA criteria, recent exacerbation requiring systemic corticosteroids or the need for medium to high-dose inhaled corticosteroids to maintain control
• Signs of acute infectious disease (i.e., acute runny nose, cough, or fever).
• Clinically relevant, uncontrolled exacerbation of another allergic disease that, in the investigator's judgement, could compromise OFC interpretation or safety (i.e., conjunctivitis, allergic rhinitis, atopic dermatitis).
• History of anaphylaxis due to cow's milk proteins within the last 6 months.
• Documented tolerance to baked CMPs or to higher steps of the milk ladder.
• Use of immunosuppressive drugs or ongoing allergen immunotherapy.

Sponsors & Collaborators

• Medical University of Warsaw: lead
• Medical University of Lublin: collaborator
• NYU Langone Health: collaborator
• University of Warmia and Mazury in Olsztyn: collaborator
• Medical University of Lodz: collaborator

Study Sites (2)

Department of Paediatrics and Allergy, Copernicus Memorial Hospital, Medical University of Lodz, Łódź, Poland

Lodz, Poland

Location

Medical Univeristy of Warsaw, Department of Paediatrics

Warsaw, Poland

Location

MeSH Terms

Conditions

Food Hypersensitivity; Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Hanna Szajewska, MD, Professor

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

• Anna Nowak-Węgrzyn, MD, Professor

  Collegium Medicum, University of Warmia and Mazury, Olsztyn, Poland; New York Univeristy, Grossmann School of Medicine

  PRINCIPAL INVESTIGATOR

• Andrea Horvath, MD, Professor

  Medical Univeristy of Warsaw

  PRINCIPAL INVESTIGATOR

• Joanna Jerzyńska, MD, PhD

  Medical Univeristy of Lodz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Horvath, MD, Professor

CONTACT

048 22 317 94 44; andrea.horvath@wum.edu.pl

Katarzyna Konieczek, MD

CONTACT

048 22 317 95 35; katarzyna.konieczek@wum.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start (Estimated): January 2, 2027
• Primary Completion (Estimated): January 2, 2030
• Study Completion (Estimated): January 2, 2030
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the publication of results, no later than 3 years from the completion of data analysis with no end date.
• Access Criteria: Upon reasonable request.

Locations

PL (2)