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

NCT ID: NCT03466931

Last Updated: 2020-06-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2021-08-30

Brief Summary

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.

Conditions

IgE-mediated Milk Allergy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dietary intervention

Meals containing Milk and Milk

Group Type: EXPERIMENTAL

Milk

Intervention Type: OTHER

Meals containing Milk and Milk

Historical cohort

Standard care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Milk

Meals containing Milk and Milk

Intervention Type: OTHER

Eligibility 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).

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital San Carlos, Madrid

OTHER

Sponsor Role: lead

Responsible Party

Inmaculada Cerecedo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Inmaculada Cerecedo, e: MD, PhD

Role: STUDY_CHAIR

Hospital Clinico San Carlos

Locations

Hospital Clinico San Carlos

Madrid, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Inmaculada Cerecedo, MD, PhD

Role: CONTACT

Inmaculada.cerecedo@salud.madrid.org

+ 34 913303000 ext. 7454

Facility Contacts

Inmuculada Cerecedo, MD, PhD

Role: primary

inmaculada.cerecedo@salud.madrid.org

+ 34 91 330 30 00 ext. 7454

Other Identifiers

Milk Ladder

Identifier Type: -

Identifier Source: org_study_id