'Specialist Infant Formulas for Non-IgE mediated Cow's Milk Allergy' study
- Conditions
- non-IgE mediated cow's milk allergy / gastro-intestinal allergy1001794710001708
- Registration Number
- NL-OMON48638
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 168
- Infants *12 months of age.
- *Suspected non-IgE mediated CMA* as defined by a symptom score of at least 15
points and the pediatrician*s opinion of a possible benefit from an elimination
diet.
- Symptoms are suspected to be related to cow's milk ingestion and not
explained otherwise.
- A parental wish for formula feeding instead of a diet based on mother*s milk.
- Expected minimum *milk* intake (per day):
Birth up to 6 months: 500 ml
From 6 months to 8 months: 450 ml
From 9 months onwards: 350 ml
- Parents/Guardians are able to understand and comply with study instructions.
- Written informed consent provided by parents/ guardians, according to local
law, to participate in this study, receive allocated treatment, fill out
diaries and questionnaires and collect saliva, stool and blood samples.
- Infants born <37 weeks gestation who require specific premature formula at
time of study entry.
- Infants less than 2500 g at birth.
- Use of any hypoallergenic formulas (partially hydrolysed formula, eHF and/or
AAF), <4 weeks prior to the first study visit, more than 1 bottle per week.
- An alternative diagnosis that is more probable than non-IgE mediated CMA (as
decided by the expert team).
- Evidence of *severe concurrent illness* (as specified in protocol).
- The use of medication (as further specified in protocol) <4 weeks prior to
the first study visit.
- Clinical history of allergy, hypersensitivity or intolerance to the
excipients of the study formulas.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study endpoints of the study are time to symptom resolution and grade<br /><br>of symptom resolution after 4 weeks of treatment. The data collected at the<br /><br>phone call after 2 weeks of treatment will also be taken into account.</p><br>
- Secondary Outcome Measures
Name Time Method <p>As secondary objectives we will assess:<br /><br>- Parent-reported data on symptoms and formula intake during the elimination<br /><br>period<br /><br>- Number of failures and remissions in each study arm (based on the symptom<br /><br>score)<br /><br>- Time point of acquired tolerance<br /><br>- Clinical effect markers; which subjects needed additional treatment with AAF<br /><br>to resolve their symptoms?<br /><br>- Biomarkers of (gut) inflammation<br /><br>- Immune status<br /><br>- Tolerance markers<br /><br>- Microbiome<br /><br>- Quality of Life (measured through the FAQLQ-PF: the food allergy related<br /><br>quality of life questionnaire for parents of children aged 0 - 12 years)</p><br>