Clinical trial NCT03661736: Growth of Infants With Cow's Milk Allergy Fed an Amino Acid-based Formula Containing Two Human Milk Oligosaccharides
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cow Milk Allergy
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2018-09-07
Enrollment: 33
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility 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.

Primary outcomes:
measure: The weight-for-age z-score (WAZ) compared with the WHO 2006 Child Growth Standard
timeFrame: Comparison of baseline WAZ vs WAZ at 4 months
Secondary outcomes:
measure: Length-for-age Z-scores (LAZ) compared with the WHO 2006 Child Growth Standard
timeFrame: 1, 2, 3, 4 months from baseline and at 12 months of age
Other outcomes:
measure: Head circumference (HCAZ) compared with the WHO 2006 Child Growth Standard
timeFrame: 1, 2, 3, 4 months from baseline and at 12 months of age
measure: Monitoring of CMPA-related symptoms
timeFrame: 1, 2, 3 and 4 months from baseline and at 12 months of age
measure: Faecal microbial composition
timeFrame: Enrolment,1, 2, 3 and 4 months from treatment start and also at 12 months of age
measure: Product compliance
timeFrame: 1, 2, 3 and 4 months from baseline and at 12 months of age
Locations:
city: Sydney
country: Australia
facility: The Children's Hospital at Westmead
state: Westmead
Study officials:
References: