Cow's milk allergy Other
Conditions
Interventions
DREAM is a parallel-group, double-blind, randomised, normal-care-controlled study that will evaluate the efficacy and safety of partially hydrolysed milk formula (pHF) fed to infants with moderate/sev
Sponsors
Manchester University NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
6 Months to 12 Months
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 18/10/2021: 1. The dose at which reactivity occurs in the DBPCFC, measured using the DBPCFC at 12 months after randomisation 2. The maximal wheal size of skin prick test to cows’ milk, measured by a skin prick test at visit 1 and visit 8 3. Specific IgE levels to cows’ milk casein, a-lactalbumin and b-lactoglobulin, measured by a blood test at visit 1 and visit 8 4. Eczema Area and Severity Index (EASI) measured using the EASI questionnaire at visits 1, 2, 3, 4, 5, 6, 7, 8, 9 5. Wheeze (during last 12 months, use of systemic steroids, hospitalizations), from medical history of wheeze collected at visits 1, 2, 3, 4, 5, 6, 7, 8, 9 6. Doctor diagnosis of other food allergies, from medical history of allergies taken at visit 1 and visit 9 7. Height measured with locally available equipment at visits 1, 2, 3, 4, 5, 6, 7, 8, 9 8. Weight measured with locally available equipment at visits 1, 2, 3, 4, 5, 6, 7, 8, 9 9. Adverse events from the visit where infants are put on the study product (V3 for ‘pHF tolerant’ and V4 for ‘pHF-reactive’ CMA infants) to the final visit (V9) ______ Previous secondary outcome measures: 1. The dose at which reactivity occurs in the DBPCFC, measured using the DBPCFC at 12 months after randomisation 2. The maximal wheal size of skin prick test to cows’ milk, measured by a skin prick test at visit 1 and visit 8 3. Specific IgE levels to cows’ milk casein, a-lactalbumin and b-lactoglobulin, measured by a blood test at visit 1 and visit 8 4. Eczema Area and Severity Index (EASI) measured using the EASI questionnaire at visits 1, 2, 3, 4, 5, 6, 7, 8, 9 5. Wheeze (during last 12 months, use of systemic steroids, hospitalizations), from medical history of wheeze collected at visits 1, 2, 3, 4, 5, 6, 7, 8, 9 6. Doctor diagnosis of other food allergies, from medical history of allergies taken at visit 1 and visit 9 7. Height measured with locally available equipment at visits 1, 2, 3, 4, 5, 6, 7, 8, 9 8. W | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactAmy Tao
Outcome results
None listed