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Partially Hydrolyzed Formula in Cow's Milk Protein Allergy After 6 Months of Elimination

NCT06130085 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-05-07

No results posted yet for this study

Summary

For Patients diagnosed as cow milk protein allergy: Elimination of cow's milk products (CMPs) for 6 months.

All infants were supplemented with Amino Acid-based Formula (AAF) (Neocate infant®/ Neocate junior®, Dannone Nutricia) for 6 months at start of elimination diet.

For mixed milk fed infants (still receiving breast milk with the formula), mothers were encouraged to continue breast-feeding while avoiding all milk and milk products from their own diet.

Intervention after completing 6 months of eliminating CMPs. The included patients were randomly assigned to one of (2 groups).

1. Group I (AAF group) n= 50 Infants in this group continued with Amino Acid-based Formula for another 6 months.
2. Group II (pHF group) n= 50 Infants in this group were shifted gradually to Partially-hydrolyzed whey formula (pHF) (Liptomil Plus HA infant formula. for another 6 months with continuation of elimination of cow's milk products.

They were followed up for manifestations of intolerance to pHF. Infant who showed manifestations of intolerance were returned to AAF and continued for 6 months with AAF.

Final step: Reintoduction of CMPs After 12 months of elimination of CMPs, evaluation of tolerance to whole CMPs was done by oral food challenge (OFC).

For infants who were still non-tolerant to CMPs after 12 months of elimination were followed up and re-challenged after 6 months.

Conditions

  • Cow's Milk Protein Allergy

Interventions

DIETARY_SUPPLEMENT

Partially hydrolyzed formula

Partially hydrolyzed formula given as the milk supplement for cow milk allergy patients after 6 months of strict elimination diet

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Months
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-15
Primary Completion
2025-01-15
Completion
2025-03-28

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 NCT06130085 on ClinicalTrials.gov