Efficacy of the "Milk Ladder" Intervention in the Development of Tolerance and the Recognition of… (NCT03466931) | Clinical Trial Compass
UnknownNot Applicable
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
Spain114 participantsStarted 2018-06-01
Plain-language 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.
Who can participate
Age range
1 Month – 12 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants that develop tolerance to milk after the 'Milk Ladder' intervention
Timeframe: 12 months
2
Number of participants experiencing any adverse reaction
Timeframe: 12 months
3
Change in antigen-specific IgE and IgG4 epitopes repertoire