Clinical Versus Home Introduction of Milk in Children with Non-IgE-mediated Cow's Milk Allergy

Launched by MARTINI HOSPITAL GRONINGEN · Mar 24, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating the best way to introduce cow's milk to infants who may have a cow's milk allergy, specifically those showing symptoms like skin redness or vomiting. The main question is whether introducing cow's milk in a hospital setting or at home is more effective in determining if these infants can safely drink it without having allergic reactions. The trial will involve two groups of infants: one group will try cow's milk in the hospital, where they will be monitored closely, and the other group will gradually introduce cow's milk at home while their parents watch for any reactions.

To be eligible for this trial, infants must be 18 months or younger and have suspected cow's milk allergies based on their medical history. However, children older than 18 months, those with confirmed allergies, or those experiencing severe allergic reactions are not eligible. Parents who join this study can expect to either bring their child to the hospital for testing or receive guidance on introducing cow's milk at home. The findings from this trial could help decide the safest approach for introducing cow's milk to infants suspected of having allergies.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • maximum age of eighteen months;
• • suspected to be allergic for cow's milk (based on medical history);
• Exclusion Criteria:
• • children older than the age of eighteen months;
• • sensitised for cow's milk (i.e. SPT \>3mm (in combination with positive control ≥3mm) or specific IgE \>0.35 kU/L)
• • patient suffers from acute (i.e. within one hour after cow's milk had been eaten) and moderate-severe IgE-mediated symptoms after ingestion of cow's milk
• • patient suffers from symptoms according to the FPIES criteria after ingestion of cow's milk
• • patient uses beta blockers and/or prednisolone;
• • patient suffers from uncontrolled respiratory symptoms or severe eczema or a chronic condition because of which the patients cannot be included as judged by the treating physician;
• • parents are unable to adequately report the occurrence of possible symptoms (e.g. insufficient language proficiency).