NCT01998074

Brief Summary

The aim of the study is to show the efficacy, tolerance and nutritional adequacy of a newly developed hydrolyzed rice formula in infants with a proven cow's milk protein allergy.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

November 22, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 28, 2013

Completed
Last Updated

November 28, 2013

Status Verified

November 1, 2013

First QC Date

November 22, 2013

Last Update Submit

November 27, 2013

Conditions

Milk HypersensitivityFood SensitivityProtein Allergy

Keywords

Cow's Milk protein Allergy

Outcome Measures

Primary Outcomes (1)

  • Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score

    at 4 weeks

Secondary Outcomes (5)

  • Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score

    at 3 months

  • Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score

    at 6 months

  • Growth (weight, height, head circumference)

    1 month

  • Growth (weight, height, head circumference)

    3 months

  • Growth (weight, height, head circumference)

    6 months

Study Arms (1)

Study formula

EXPERIMENTAL
Dietary Supplement: extensively hydrolyzed rice protein formula

Interventions

extensively hydrolyzed rice protein formulaDIETARY_SUPPLEMENT
Study formula

Eligibility Criteria

Age2 Weeks - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants between 2 weeks and 6 months old
  • In whom cow's Milk Protein Allergy has been proved by a food challenge performed during the previous month

You may not qualify if:

  • Exclusively breast fed infants
  • Preterm infants
  • Infants already fed with an extensively hydrolyzed formula with no improvement of the symptoms.
  • Infants fed an amino acid based formula
  • Infants who had an anaphylactic reaction in the past

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitair Ziekenhuis

Brussels, 1090, Belgium

Location

Related Publications (1)

  • Vandenplas Y, De Greef E, Hauser B; Paradice Study Group; Paradice Study Group. An extensively hydrolysed rice protein-based formula in the management of infants with cow's milk protein allergy: preliminary results after 1 month. Arch Dis Child. 2014 Oct;99(10):933-6. doi: 10.1136/archdischild-2013-304727. Epub 2014 Jun 9.

    PMID: 24914098DERIVED

MeSH Terms

Conditions

Milk HypersensitivityFood Intolerance

Condition Hierarchy (Ancestors)

Food HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2013

First Posted

November 28, 2013

Primary Completion

November 1, 2013

Last Updated

November 28, 2013

Record last verified: 2013-11

Locations

BE(1)