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Completed

NCT Number: NCT03661736

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

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.

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Key information

Conditions

Cow Milk Allergy Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Milk Hypersensitivity

Age range

1 month–8 month

Sex eligibility

All sexes

Study type

Observational

Primary location

The Children's Hospital at Westmead

Sydney, Westmead, 2145, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Food for Specific Medical Purpose

Other

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

Primary outcomes

  1. The weight-for-age z-score (WAZ) compared with the WHO 2006 Child Growth Standard

    Time frame: Comparison of baseline WAZ vs WAZ at 4 months

    Weight gain will be measured in kg and converted to WAZ scores

Secondary outcomes

  1. Length-for-age Z-scores (LAZ) compared with the WHO 2006 Child Growth Standard

    Time frame: 1, 2, 3, 4 months from baseline and at 12 months of age

    Body length will be measured in cm and converted to LAZ scores

Other outcomes

  1. Head circumference (HCAZ) compared with the WHO 2006 Child Growth Standard

    Time frame: 1, 2, 3, 4 months from baseline and at 12 months of age

    Head circumference will be measured in cm converted to HCAZ scores

  2. Monitoring of CMPA-related symptoms

    Time frame: 1, 2, 3 and 4 months from baseline and at 12 months of age

    CMPA-related symptoms will be documented by the study physician on data collection forms

  3. Faecal microbial composition

    Time frame: Enrolment,1, 2, 3 and 4 months from treatment start and also at 12 months of age

    Faecal samples will be collected before and after the study formula ingestion

  4. Product compliance

    Time frame: 1, 2, 3 and 4 months from baseline and at 12 months of age

    Daily quantity consumed (mL) will be recorded for the 3 days preceding each visit in a diary given to the parent or caregiver

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

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

Acronym: PLATYPUS

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 7, 2018
Registry last updated
Dec 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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