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

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ClinicalTrials.gov Identifier: NCT03661736
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
Nestlé

Brief 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.

Condition or disease Intervention/treatment
Cow Milk Allergy Other: Food for Specific Medical Purpose

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Actual Study Start Date : April 12, 2018
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy


Intervention Details:
  • 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


Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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


Biospecimen Retention:   Samples With DNA
Stool samples


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 8 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03661736


Contacts
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Contact: Monika Tadi, PhD 0041219244100 monika.tadi@nestle.com

Locations
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Australia, Westmead
The Children's Hospital at Westmead Recruiting
Sydney, Westmead, Australia, 2145
Contact: Dianne Campbell         
Sponsors and Collaborators
Nestlé

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Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT03661736    
Other Study ID Numbers: 17.09.CLI
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypersensitivity
Milk Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate