Cow Milk AllergyPLATYPUSNCT03661736
Growth of Infants With Cow's Milk Allergy Fed an Amino Acid-based Formula Containing Two Human Milk Oligosaccharides
An observational study of Cow Milk Allergy, run by Société des Produits Nestlé (SPN) at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 8 monthsHealthy volunteers can take part
- Conditions the study is for
- Cow Milk Allergy
- What is being tested?
- Food for Specific Medical Purpose
- How many people
- 33 participants
- Where
- 1 siteAustralia
- Study dates
- 12 Apr 2018to 30 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 8 months
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- 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:
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Cow Milk Allergy
- Being tested
- Food for Specific Medical Purpose
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food for Specific Medical PurposeOther
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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Comparison of baseline WAZ vs WAZ at 4 months
Secondary outcomes (1)
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
Measured: 1, 2, 3, 4 months from baseline and at 12 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start12 Apr 2018
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cow Milk AllergyStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661736
- Sponsor's protocol ID
- 17.09.CLI
- Acronym
- PLATYPUS
- Status last verified
- Aug 2020
- First submitted
- 22 Aug 2018
- Last updated
- 21 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03661736
- Acronym / sponsor ID
- PLATYPUS / 17.09.CLI
- Conditions
- Cow Milk Allergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 12 Apr 2018 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 7 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 8 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food for Specific Medical PurposeInfants 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 | Other | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cow Milk Allergy, run by Société des Produits Nestlé (SPN) at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2020.