Desensitisation regimens in milk allergy

Not Applicable

• Conditions: Cow's milk allergy; Not Applicable

• Registration Number: ISRCTN37753699
• Lead Sponsor: Manchester University NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-08
• Last Update Posted: 8 January 2024
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: Stopped
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Visit 1 Inclusion Assessments:
1. Infant aged 6 to 12 months, inclusive at visit 1
2. Convincing medical history of IgE-mediated allergic reaction following ingestion of cow’s milk formula, as determined by trial physician
3. Infant fed with formula, either exclusively or mixed with breastfeeding
4. Weight of at least 7.5 kg
5. Written informed consent by parent/legal guardian prior to completing any study-related procedure
6. Titre of cow’s milk-specific IgE in serum, equal or higher to 2 kU/L (collected at visit 1, confirmed prior to visit 2/3), at inclusion or wheal reaction of equal or over 5mm to SPT* to CM at inclusion

Visit 2/3 Inclusion Assessments:
7. Positive result in the challenge to pHF (V2) or positive result in the challenge to CM (V3)

Added 17/05/2022:
*5 mm to either whole, fresh milk, or commercial milk extract

Exclusion Criteria

Visit 1 Exclusion Assessments:
1. Unequivocal history of severe anaphylaxis to CM in the past requiring more than one dose of adrenaline
2. Doctor diagnosis of non-IgE-mediated allergy to cows’ milk or cows’ milk formula (eosinophilic esophagitis, gastritis, gastroenteritis, FPIES, enteropathies and proctocolitis). Worsening of pre-existing eczema due to CM consumption is not an exclusion criterion. Added 17/05/2022: Onset or worsening of pre-existing eczema due to CM consumption is not an exclusion criterion
3. Any significant clinical condition that may interfere with patient’s safety or the study outcomes. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, immunological and endocrine disease
4. Requirement for continuous or frequent (monthly or more) intermittent use of oral corticosteroids for other conditions
5. Requirement for pharmacotherapy for any other clinical condition, if it could interfere with the patient’s safety or the study outcomes
6. Parents or guardians, who, by investigator judgment, are unlikely to comply with the study protocol for any reason (language barrier, communication issues, inability to understand procedures, etc)
7. History of overnight hospitalisation (only A&E attendances not included) for wheeze and/or bronchiolitis on more than one occasion
8. Currently participating in another clinical trial that may interfere with the patient’s safety or the study outcomes

Added 17/05/2022: 9. Another infant from the same household is currently participating in the study

Visit 2/3 Exclusion Assessments:
10. Severe anaphylaxis (anaphylaxis refractory to a single dose of intramuscular adrenaline) during challenge to pHF or CM

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CM tolerance assessed using a double-blind, placebo-controlled food challenge (DBPCFC) at 12 months after randomisation (randomisation will take place at V2 for pHF-reactive infants and V3 for pHF-tolerant infants)