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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-12

Study Completion Date

2020-10-30

Brief Summary

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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

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Conditions

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Cow Milk Allergy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

1 Month

Maximum Eligible Age

8 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Children's Hospital at Westmead

Sydney, Westmead, Australia

Site Status

Countries

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Australia

Other Identifiers

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17.09.CLI

Identifier Type: -

Identifier Source: org_study_id