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Efficacy of the "Milk Ladder" Intervention in the Development of Tolerance and the Recognition of B Cell Epitopes in Babies Who Are Allergic to Cow's Milk Proteins

Study Purpose

Food allergies have become a relevant health problem in westernized societies, particularly, with children. Cow's milk (CM), along with hen's eggs, are the most common foods eliciting allergic reactions in children under 4 years of age. The main objective of this intervention study is to evaluate the safety and efficacy of the intervention known as "The Milk Ladder" in the development of tolerance by children with CM allergies. This will be compared to an historical cohort (CoALE), which investigated the natural history of this allergy. Additionally, the ability of informative epitopes will be evaluated for their potential to predict tolerance and their correlation against clinical variables. The "Milk Ladder" will be evaluated within a prospective cohort of CM allergic children. This intervention is enacted through the introduction of meals cooked with progressively increasing amounts of cow's milk into the participant's diet. The primary outcome will be the development of tolerance which will be evaluated through a double-blind placebo-controlled food challenge. IgE and IgG4 epitopes will be described using a peptide microarray immunoassay. Quality of life will be determined by administering the FAQLQ-PF disease-specific questionnaire. Finally, within a subgroup of study participants, the ability of different peptides to activate basophils will be analyzed, and CM T cell epitopes will be studied by means of T-cell proliferation and cytokine production assays.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 1 Month - 12 Months
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Babies of both sexes.
  • - Age < 12 months.
  • - Clinical history of immediate reaction (<2 hours) after the intake of baby's formula and/or foods containing cow's milk.
  • - Sensitization to cow's milk proteins demonstrated by: - sIgE to cow's milk, alpha-Lactoabumin, beta-Lactoglobulin and/or Casein >0.1KU/l (ImmunoCAP®, ThemoFisher) and/or.
  • - Skin prick test to cow's milk, alpha-Lactoabumin, beta-Lactoglobulin and/or Casein ≥3mm.
  • - If the reaction to milk occurred over 3 months before the recruitment, it will be mandatory to confirm reactivity to milk with an oral food test.
  • - Parents / legal representatives of the participant voluntary accept to participate.

Exclusion Criteria:

  • - Delayed reactions (> 2 h) after milk intake.
  • - Contact urticaria to milk if ingestion is well tolerated.
  • - Previous participation in oral tolerance induction/desensitization protocols.
  • - Treatment with any medication that might interfere the evaluation of the primary outcome or any study procedure.
  • - Any disease or condition which presents a contraindication to perform an oral challenge, either open or double-blind or any other study procedure.
  • - Social circumstances that might interfere with protocol adherence.
  • - Egg and/or wheat allergy (this exclusion criterion shall be verified before the beginning of the intervention).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hospital San Carlos, Madrid
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Inmaculada Cerecedo, e: MD, PhD
Principal Investigator Affiliation Hospital Clinico San Carlos
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries Spain

The disease, disorder, syndrome, illness, or injury that is being studied.

IgE-mediated Milk Allergy
Arms & Interventions


Experimental: Dietary intervention

Meals containing Milk and Milk

No Intervention: Historical cohort

Standard care


Other: - Milk

Meals containing Milk and Milk

Contact a Trial Team

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International Sites

Hospital Clinico San Carlos, Madrid, Spain




Hospital Clinico San Carlos

Madrid, , 28040

Site Contact

Inmuculada Cerecedo, MD, PhD


+ 34 91 330 30 00 #7454

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