Symptoms Based Awareness Confirmation Study - CoMiSS Validation

Study Overview
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Brief Summary
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The Cow's Milk-related Symptom Score (CoMiSS) tool has been developed to define a score to recognize cow's milk related symptoms in infants and young children. Many infants and toddlers with symptoms that can be related to intake of cow's milk and cow's milk protein allergy (CMPA) are often not diagnosed due to the lack of specific markers. The goal of this trial is to validate the CoMiSS tool in infants suspected of CMPA and investigate if the CoMiSS tool could be an alternative to the open challenge test needed to confirm the diagnosis of Cow Milk Protein Allergy.

Official Title
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Symptoms Based Awareness Confirmation Study - CoMiSS Validation

Conditions
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Cow Milk Allergy

Intervention / Treatment
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* Other: CoMiSS questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female infant aged up to 6 months old Has been fed exclusively on cow's milk infant formula for at least one week Has CMPA symptoms that have been present for at least one week, and that developed within the first two months of starting cow's milk infant formula In the opinion of the investigator, requires a two week elimination diet with Amino Acid Formula (AAF). Had a gestational age at birth of 37 to 42 weeks Had a birthweight of 2500 g to 4500 g Informed consent signed by both parents, liable parent or legal guardian (if applicable). Exclusion Criteria: Has ever received either an extensively hydrolysed infant formula or an AAF prior to enrolment Has a fever above 38.5°C at enrolment Has ever experienced a medically diagnosed serious anaphylactic reaction Use of antibiotic drugs at enrolment. Infants may be enrolled if antibiotics have been stopped at least 7 days prior to enrolment. (Antibiotic treatment can be initiated during the study if an infant develops a condition after enrolment that requires antibiotic treatment). Infant with a health condition or family situation that makes the infant unsuitable to participate in the trial according to the opinion of the investigator Infant or infant's carers are unable to comply with trial procedures Currently participating or has participated in another clinical trial within 4 weeks prior to trial start.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CoMiSS<br>Measure of CoMiSS followed by two weeks eviction Cow's milk protein diet and second CoMiSS measurement. | Other: CoMiSS questionnaire<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The accuracy in terms of the Area Under Curve (AUC) of the Receiver Operating Characteristic (ROC) curve of the change in CoMiSS. |  | baseline, Week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CoMiSS and component scores |  | baseline, Week 2, Week 4 | 
| Family history of atopy |  | baseline | 
| Method of delivery at birth |  | baseline | 
| Anthropometric measurements |  | baseline | 
| Volume intake of Alfamino formula every day |  | baseline, week 2 | 
| Physician's assessment of the likelihood that a subject has CMPA |  | baseline, week 2 | 
| The result of Oral food Challenge (OFC) |  | week 2, Week 4 | 
| Compliance to elimination diet |  | week 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergy, Atopic Dermatitis, Immunoglobulin E (IgE), CMPA