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

Cow Milk Allergy Clinical Trial

— PLATYPUS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03661736
• Other study ID #: 17.09.CLI
• Status: Completed
• Start date: April 12, 2018
• Est. completion date: October 30, 2020

Study information

• Verified date: August 2020
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 8 Months

Eligibility

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.

Related Conditions & MeSH terms

• Cow Milk Allergy
• Hypersensitivity
• Milk Hypersensitivity

Intervention

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

Locations

Country	Name	City	State
Australia	The Children's Hospital at Westmead	Sydney	Westmead

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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	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