Clinical trial NCT05960045: Testing Tolerance in Cow Milk Protein Allergy Patients: Milk Ladder or Direct Milk Administration?
Official title: Testing Tolerance in Cow Milk Protein Allergy Patients: Milk Ladder or Direct Milk Administration?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cow Milk Allergy
Tolerance
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 116
Sex: ALL
Minimum age (years): 9
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups
Primary purpose: OTHER

Brief summary: Majority of children outgrow their allergies, however there are two different methods to re-introduce milk products in the infant diet either direct milk intake in escalating doses or milk ladder, starting with baked milk products instead of pure milk.

This study aims to compare rate of tolerance after milk reintroduction among patient with cow milk protein allergy (CMPA) diagnosed by elimination re-challenge test after six months of elimination diet by milk ladder versus direct milk intake.

Detailed description: CMPA is an immunological response to one or more milk proteins. CMPA may be IgE mediated or Non-IgE mediated. It is one of the most frequent causes of food allergies in young children with an estimated prevalence between 1.9% and 4.9% in the first year of life.

CMPA has a good prognosis and cow milk is reintroduced in child diet. Natural history of CMPA shows heterogeneity and it is closely related to the clinical phenotype by which it was presented.

The timing and evaluation of developing tolerance is determined by clinical response to milk introduction.

When diagnosis of CMPA is confirmed, fresh pasteurized cow's milk can be used above 12 months of age in oral food challenge procedure, the starting dose should be lower than a dose that can induce a reaction and then increased step wise to 100ml, in children with mild to moderate reactions doses of 1ml, 3ml, 10ml, 30ml, and 100ml may be given at 30 minutes' intervals.

The milk ladder is an evidence-based plan to re-introduce milk products gradually and in stages for infants and children with mild to moderate cow's milk allergy, starting with food that contain only small amount of well-cooked milk and progressing towards uncooked dairy products and fresh milk. It's only started once child has been on a milk free diet for at least 6 months and they are completely well with no active eczema or gastro-intestinal symptoms.

Addition of baked- milk to the diet appears to accelerate the development of unheated-milk tolerance compared to strict avoidance, also its consumption is considered a form of immunotherapy with favorable safety, higher convenience, lower cost and less intensity when compared to oral immunotherapy. It's suggested to enhance the quality of life by removing unnecessary dietary restrictions and change the natural evaluation of milk allergy by promoting the development of tolerance to regular cow's milk.

Eligibility criteria: Inclusion Criteria:

1. Patients age between 9 months old till 3 years old.
2. Patients with symptoms that suggest mild to moderate non IgE mediated Cow Milk Allergy
3. Patients on strict elimination diet for at least six months duration

Exclusion Criteria:

Patient with:

* Chronic gastrointestinal disease (malabsorption, irritable bowel syndrome).
* Multiple food allergy and/or history of anaphylaxis.
* Ongoing eczema or severe gastrointestinal symptoms.

Primary outcomes:
measure: Compare the frequency of tolerance to milk between the two groups
timeFrame: intervention will be made six months of elimination diet, and follow up of 2 months later
Secondary outcomes:
measure: Recording of overall percentage of milk tolerance after 6 months elimination diet
timeFrame: intervention will be made six months of elimination diet, and follow up of 2 months later
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: AinShams University
name: Ahmed Saber
role: STUDY_DIRECTOR
affiliation: AinShams university
name: Yasmine El-Gendy
role: STUDY_DIRECTOR
affiliation: Ain Shams University
name: Yosra Awad
role: STUDY_DIRECTOR
affiliation: Ain Shams University
name: Nesreen Hammad
role: STUDY_DIRECTOR
affiliation: Ain Shams University
name: Mostafa EL-Hodhod
role: PRINCIPAL_INVESTIGATOR
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