Cow Milk Allergy
Conditions
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.
Interventions
OTHERFood 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
Sponsors
Société des Produits Nestlé (SPN)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Months to 8 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Head circumference (HCAZ) compared with the WHO 2006 Child Growth Standard | 1, 2, 3, 4 months from baseline and at 12 months of age | Head circumference will be measured in cm converted to HCAZ scores |
| Monitoring of CMPA-related symptoms | 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 |
| Faecal microbial composition | 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 |
| Product compliance | 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 |
Countries
Australia
Outcome results
None listed