Step Down Approach in Children With Cow Milk Allergy

NCT03449537 | Completed

• 1 other identifier: 284/17
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Cow's milk allergy (CMA) affects up to 3% of European children. In the absence of an alternative to cow's milk, the management of CMA is based on the use of safe, affordable and nutritionally adequate formulas. In Scientific Societies Guidelines, extensively hydrolyzed casein formula (EHCF) is considered as safe first line approach for the treatment of children with CMA, whereas amino acid-based formula (AAF) is considered as second line strategy in children reacting to EHCF or as first line approach in children with CMA-induced anaphylaxis. Few and not recent studies, involving a poorly characterized study population, suggested that up to 10% of CMA children could react to the extensively hydrolysed formulas. It has been demonstrated that EHCF supplemented with L.rhamnosus GG (LGG) maintains hypoallergenic status and that is able to accelerate oral tolerance acquisition in children with CMA comparing with other formulas. The purpose of this study is to investigate the feasibility of a "step-down" approach in children affected by Immunoglobulin E (IgE)-mediated CMA with the aim to evaluate the effects of EHCF + LGG on oral tolerance acquisition and on immune response and gut microbiota shaping.

Conditions

Allergy Milk

Outcome Measures

Primary Outcomes (1)

• Evaluation of the tolerance rate of EHCF+LGG in CMA children treated with AAF

  tolerance to extensively hydrolyzed casein formula, i.e. the ability to eat EHCF formula (at least 100 ml/day) without sign and symptoms related to allergy

  after the first oral food challenge, i.e. after 7-15 days after inclusion

Secondary Outcomes (9)

• Immune tolerance acquisition to cow milk in children treated with EHCF + LGG comparing with children assuming AAF, i.e. the ability to eat cow milk (at least 100 ml/day)

  after 12 months of intervention

• auxological parameters comparing the two groups

  after 6 and 12 months of intervention

• body growth comparing the two groups

  after 6 and 12 months of intervention

• Changing in allergological screening test comparing the two groups

  after 6 and 12 months of intervention

• Changing in immunoglobulin comparing the two groups

  after 6 and 12 months of intervention

Study Arms (2)

EHCF+LGG

EXPERIMENTAL

extensively hydrolyzed casein formula supplemented with the probiotic Lactobacillus rhamnosus GG

Dietary Supplement: extensively hydrolyzed casein formula + LGG

AAF

ACTIVE COMPARATOR

hypoallergenic formula based on amino acid-based formula

Dietary Supplement: Hypoallergenic formula based on amino-acid based formula

Interventions

extensively hydrolyzed casein formula + LGG DIETARY_SUPPLEMENT

Hypoallergenic formula based on extensively hydrolyzed casein supplemented with the probiotic Lactobacillus rhamnosus GG

EHCF+LGG

Hypoallergenic formula based on amino-acid based formula DIETARY_SUPPLEMENT

Hypoallergenic formula for cow milk allergy treatment based on amino acids

AAF

Eligibility Criteria

• Age: 0 Months - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants aged \<6 months
• sure diagnosis of IgE-mediated CMA confirmed by positive oral food challenge for cow's milk and or blood Cow milk protein specific IgE\>0.1kiloUnits/Liter and/or Skin Prick Testing (SPT) for milk wheal size ≥ 3mm
• children receiving AAF for at least 4 weeks
• full and stable remission of CMA symptoms.

You may not qualify if:

• Infant aged \> 6 months,
• CMP-induced anaphylaxis,
• evidence of non-IgE-mediated CMA,
• other food allergies,
• other allergic diseases,
• eosinophilic disorders of the gastrointestinal tract,
• chronic systemic diseases,
• congenital cardiac defects,
• active tuberculosis,
• autoimmune diseases,
• immunodeficiency,
• chronic inflammatory bowel diseases,
• celiac disease,
• cystic fibrosis,
• metabolic diseases,

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Department of Traslational Medical Science - University of Naples Federico II

Naples, 80131, Italy

Location

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Head of Pediatric Allergology

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: February 28, 2018
• Study Start: April 1, 2018
• Primary Completion: October 28, 2020
• Study Completion: December 31, 2020
• Last Updated: February 22, 2024

Record last verified: 2024-02

Locations

IT (1)