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

NCT03661736 | Completed

• 1 other identifier: 17.09.CLI
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Cow Milk Allergy

Outcome Measures

Primary Outcomes (1)

• The weight-for-age z-score (WAZ) compared with the WHO 2006 Child Growth Standard

  Weight gain will be measured in kg and converted to WAZ scores

  Comparison of baseline WAZ vs WAZ at 4 months

Secondary Outcomes (1)

• 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

Other Outcomes (4)

• Head circumference (HCAZ) compared with the WHO 2006 Child Growth Standard

  1, 2, 3, 4 months from baseline and at 12 months of age

• Monitoring of CMPA-related symptoms

  1, 2, 3 and 4 months from baseline and at 12 months of age

• Faecal microbial composition

  Enrolment,1, 2, 3 and 4 months from treatment start and also at 12 months of age

Interventions

Food for Specific Medical Purpose OTHER

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

Eligibility Criteria

• Age: 1 Month - 8 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

• Full term infant (37 weeks ≤ gestation ≤ 42 weeks)
• g ≤ birth weight ≤ 4500g
• Having obtained written informed consent form the infant's parents or legally authorized representatives (LAR).
• Infant aged between 1 and 8 months.
• 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.
• Infants with physician-diagnosed CMPA as per standard clinical practice:

You may not qualify if:

• Previous treatment with AAF \> 72 hours
• 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.)
• Demonstrated chronic malabsorption which is not due to CMPA.
• Other significant pre-natal and/or serious post-natal disease other than CMPA before enrolment (per investigator's medical decision).
• Infants whose parents or caregivers who cannot give informed consent or who cannot be expected to comply with study procedures.
• Treatment with systemic corticosteroids (oral or intravenous) for \>72 hours within 4 weeks before enrolment (topical corticosteroids allowed)
• Infants taking probiotic preparations for \> 72 hour within 4 weeks before enrolment
• Currently participating or having participated in another clinical trial since birth.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

The Children's Hospital at Westmead

Sydney, Westmead, 2145, Australia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples

MeSH Terms

Conditions

Milk Hypersensitivity

Interventions

Food

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: September 7, 2018
• Study Start: April 12, 2018
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: December 21, 2020

Record last verified: 2020-08

Locations

AU (1)