Growth of Infants With Cow's Milk Allergy Fed an Amino Acid-based Formula Containing Two Human Milk Oligosaccharides

Study Overview
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Brief Summary
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The main aim of this study is to provide longitudinal growth data in infants with moderate-to-severe cow's milk allergy fed an amino acid-based formula with two added human milk oligosaccharides.

Official Title
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Growth of Infants With Cow's Milk Allergy Fed an Amino Acid-based Formula Containing Two Human Milk Oligosaccharides: Comparison With World Health Organization (WHO) Growth Standards in an Observational, Single-arm Study

Conditions
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Cow Milk Allergy

Intervention / Treatment
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* Other: Food for Specific Medical Purpose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Full term infant (37 weeks ≤ gestation ≤ 42 weeks) 2500g ≤ birth weight ≤ 4500g Having obtained written informed consent form the infant's parents or legally authorized representatives (LAR). Infant aged between 1 and 8 months. Exclusively formula-fed at time of enrolment; or CMPA infant receiving partial breastfeeding and infant's mother having independently elected before enrolment to exclusively formula feed. Infants with physician-diagnosed CMPA as per standard clinical practice: Exclusion Criteria: Previous treatment with AAF > 72 hours Known underlying medical condition that would impair growth (as per physician's assessment, e.g. unstable congenital heart disease, cystic fibrosis, metabolic disorder, chronic liver disease etc.) Demonstrated chronic malabsorption which is not due to CMPA. Other significant pre-natal and/or serious post-natal disease other than CMPA before enrolment (per investigator's medical decision). Infants whose parents or caregivers who cannot give informed consent or who cannot be expected to comply with study procedures. Treatment with systemic corticosteroids (oral or intravenous) for >72 hours within 4 weeks before enrolment (topical corticosteroids allowed) Infants taking probiotic preparations for > 72 hour within 4 weeks before enrolment Currently participating or having participated in another clinical trial since birth.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 8 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Food for Specific Medical Purpose|Infants aged 1 to 8 months with moderate-to-severe cow's milk allergy fed an amino acid-based formula with two added human milk oligosaccharides|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The weight-for-age z-score (WAZ) compared with the WHO 2006 Child Growth Standard | Weight gain will be measured in kg and converted to WAZ scores | Comparison of baseline WAZ vs WAZ at 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length-for-age Z-scores (LAZ) compared with the WHO 2006 Child Growth Standard | Body length will be measured in cm and converted to LAZ scores | 1, 2, 3, 4 months from baseline and at 12 months of age |