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

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

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

NCT03661736•Société des Produits Nestlé (SPN)

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Full term infant (37 weeks ≤ gestation ≤ 42 weeks)
•2. 2500g ≤ birth weight ≤ 4500g
•3. Having obtained written informed consent form the infant's parents or legally authorized representatives (LAR).
•4. Infant aged between 1 and 8 months.
•5. 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.
•6. Infants with physician-diagnosed CMPA as per standard clinical practice:

Exclusion Criteria

•1. Previous treatment with AAF \> 72 hours
•2. 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.)
•3. Demonstrated chronic malabsorption which is not due to CMPA.
•4. Other significant pre-natal and/or serious post-natal disease other than CMPA before enrolment (per investigator's medical decision).
•5. Infants whose parents or caregivers who cannot give informed consent or who cannot be expected to comply with study procedures.
•6. Treatment with systemic corticosteroids (oral or intravenous) for \>72 hours within 4 weeks before enrolment (topical corticosteroids allowed)
•7. Infants taking probiotic preparations for \> 72 hour within 4 weeks before enrolment
•8. Currently participating or having participated in another clinical trial since birth.

Locations (1)

The Children's Hospital at Westmead

Sydney, Westmead, Australia

Key Dates

Start Date

April 12, 2018

Primary Completion Date

October 30, 2020

Completion Date

October 30, 2020

Last Updated

December 21, 2020

Enrollment

ACTUAL participants

Conditions

Cow Milk Allergy

Interventions

Food for Specific Medical Purpose

OTHER

Clinical Versus Home Introduction of Milk in Children with Non-IgE-mediated Cow's Milk Allergy

NCT05785299

Cow Milk AllergyFood Allergy

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ACTIVE_NOT_RECRUITING

Detection of Metabolite Biomarkers for the Early Diagnosis and Prognosis of Cow's Milk Allergy in Children

NCT04249973

Cow Milk AllergyFood Allergy

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 21, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Clinical Versus Home Introduction of Milk in Children with Non-IgE-mediated Cow's Milk Allergy

Detection of Metabolite Biomarkers for the Early Diagnosis and Prognosis of Cow's Milk Allergy in Children

Epigenetic Effects in Children With Cow's Milk Allergy Treated With Different Formulas

The Frequency of Beef Allergy in Children With Cow Milk Allergy

Synbiotic Extensively Hydrolysed Feed Study

Growth and Plasma Amino Acids in Infants With CMPA and Treated With a Newly Innovated Amino Acid Formula