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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	1 Month - 8 Months
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03661736
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Nestlé
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Active, not recruiting
Countries	Australia
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cow Milk Allergy

Contact a Trial Team

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International Sites

The Children's Hospital at Westmead, Sydney, Westmead, Australia

Status

Address

The Children's Hospital at Westmead

Sydney, Westmead, 2145

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