- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03466931
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
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.
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Inmaculada Cerecedo, MD, PhD
- Phone Number: 7454 + 34 913303000
- Email: Inmaculada.cerecedo@salud.madrid.org
Study Locations
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-
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Madrid, Spain, 28040
- Recruiting
- Hospital Clinico San Carlos
-
Contact:
- Inmuculada Cerecedo, MD, PhD
- Phone Number: 7454 + 34 91 330 30 00
- Email: inmaculada.cerecedo@salud.madrid.org
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dietary intervention
Meals containing Milk and Milk
|
Meals containing Milk and Milk
|
No Intervention: Historical cohort
Standard care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants that develop tolerance to milk after the 'Milk Ladder' intervention
Time Frame: 12 months
|
Tolerance assessment: participants who successfully pass a double-blind placebo-controlled oral food challenge without experiencing any limiting symptom
|
12 months
|
Number of participants experiencing any adverse reaction
Time Frame: 12 months
|
Number of participants experiencing any adverse reaction to milk-containing foods along the intervention assessed by Medical Dictionary for Regulatory Activities (MedDRA), version in place at the end of the study.
|
12 months
|
Change in antigen-specific IgE and IgG4 epitopes repertoire
Time Frame: 6 and 18 months
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Serum specific inmunnoglobulin levels using a milk peptide microarray immunoassay
|
6 and 18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life
Time Frame: 6 and 18 months
|
Change in quality of life total score during the intervention, assessed by the disease-specific questionnaire 'Food Allergy Quality of Life Questionnaire - Parent Form'
|
6 and 18 months
|
Potential T-cell epitopes
Time Frame: 12 months
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Identification of potential T-cell epitopes in serum assessed by a T lymphocyte proliferation assay and cytokine secretion
|
12 months
|
Ability of the milk allergenic peptides to activate basophils
Time Frame: 12 months
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In vitro determination of basophil activation upon antigen stimulation
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12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Inmaculada Cerecedo, e: MD, PhD, Hospital Clinico San Carlos
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Milk Ladder
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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