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Testing Tolerance in Cow Milk Protein Allergy Patients: Milk Ladder or Direct Milk Administration?

NCT05960045 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2025-05-07

No results posted yet for this study

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.

Conditions

  • Cow Milk Allergy
  • Tolerance

Interventions

DIETARY_SUPPLEMENT

Direct Milk antigen reintroduction

Direct milk antigen re-introduction milk according to ESPGHAN guidelines

DIETARY_SUPPLEMENT

Milk ladder

B: Milk ladder according to the iMAP guideline which are 6 weeks of gradual reintroduction starting with baked milk not direct antigen

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Ahmed Saber · AinShams University

  • Yasmine El-Gendy · AinShams university

  • Yosra Awad · Ain Shams University

  • Nesreen Hammad · Ain Shams University

  • Mostafa EL-Hodhod · Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
9 Months
Max Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2025-04-15
Completion
2025-04-28

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05960045 on ClinicalTrials.gov