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

Completed

• Conditions: Cow Milk Allergy

• Registration Number: NCT03661736
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-12
• Study First Submitted: 2018-08-22
• Study First Submitted QC: 2018-09-05
• Study First Posted: 2018-09-07
• Status Verified: 2020-08
• Primary Completion: 2020-10-30
• Study Completion: 2020-10-30
• Last Update Submitted: 2020-12-18
• Last Update Posted: 2020-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The weight-for-age z-score (WAZ) compared with the WHO 2006 Child Growth Standard	Comparison of baseline WAZ vs WAZ at 4 months	Weight gain will be measured in kg and converted to WAZ scores

Secondary Outcome Measures

Name	Time	Method
Length-for-age Z-scores (LAZ) compared with the WHO 2006 Child Growth Standard	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

Trial Locations

Locations (1)

The Children's Hospital at Westmead; 🇦🇺 Sydney, Westmead, Australia