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

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

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.

Study Overview

• Status: Completed
• Conditions: Cow Milk Allergy
• Intervention / Treatment: Other: Food for Specific Medical Purpose

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• Australia
  • Westmead
    • Sydney, Westmead, Australia, 2145
      • The Children's Hospital at Westmead

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 8 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Full-term infants 1-8 months of age with symptoms suggestive of moderate-to-severe CMPA who have failed a trial of extensively hydrolyzed formula (EHF) of at least 2 weeks or who require amino acid formula as first line of treatment

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Head circumference (HCAZ) compared with the WHO 2006 Child Growth Standard	Head circumference will be measured in cm converted to HCAZ scores	1, 2, 3, 4 months from baseline and at 12 months of age
Monitoring of CMPA-related symptoms	CMPA-related symptoms will be documented by the study physician on data collection forms	1, 2, 3 and 4 months from baseline and at 12 months of age
Faecal microbial composition	Faecal samples will be collected before and after the study formula ingestion	Enrolment,1, 2, 3 and 4 months from treatment start and also at 12 months of age
Product compliance	Daily quantity consumed (mL) will be recorded for the 3 days preceding each visit in a diary given to the parent or caregiver	1, 2, 3 and 4 months from baseline and at 12 months of age

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2018
• Primary Completion (Actual): October 30, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: August 22, 2018
• First Submitted That Met QC Criteria: September 5, 2018
• First Posted (Actual): September 7, 2018

Study Record Updates

• Last Update Posted (Actual): December 21, 2020
• Last Update Submitted That Met QC Criteria: December 18, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Milk Hypersensitivity
• Other Study ID Numbers: 17.09.CLI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No