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

Launched by AIN SHAMS UNIVERSITY · Nov 11, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how well infants with a cow's milk protein allergy (CMPA) can tolerate a specific type of formula after completely avoiding cow's milk products for six months. During the first phase of the study, all participating infants received an amino acid-based formula, which is specially made for babies with allergies. After six months, the infants were randomly divided into two groups. One group continued with the amino acid formula, while the other group gradually switched to a partially-hydrolyzed whey formula, which is easier to digest. The goal is to see how well the infants tolerate this new formula.

To be eligible for this trial, infants must be artificially fed, either exclusively or with some additional foods, and they must have a confirmed diagnosis of cow's milk protein allergy. It's important to note that exclusively breastfed infants and those with severe allergic reactions or multiple food allergies are not eligible. Throughout the study, participants will be monitored for any signs of intolerance to the new formula. After a total of twelve months of avoiding cow's milk, the infants will undergo a test to see if they can safely consume cow's milk products again. If they still show symptoms of intolerance, they will be followed up and tested again after another six months. This trial aims to find the best way to manage cow's milk protein allergies in young infants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Artificially fed infants whether exclusively or complementary.
• • 2. Confirmed diagnosis of CMPA based on clinical symptoms and signs and followed by withdrawal open re-challenge test
• Exclusion Criteria:
• • 1. Exclusively breast-fed infants.
• • 2. Anaphylactic type.
• • 3. Multiple food Allergies.