NCT02351531

Brief Summary

The aim of the study is to assess the hypoallergenicity of a new thickened extensively hydrolyzed formula.

Trial Health

85
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at below P25 for phase_3

Geographic Reach
3 countries

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 30, 2015

Completed
Last Updated

January 30, 2015

Status Verified

January 1, 2015

Enrollment Period

1.1 years

First QC Date

January 21, 2015

Last Update Submit

January 27, 2015

Conditions

Cow Milk Allergy

Outcome Measures

Primary Outcomes (1)

  • Number of patients dropped out for intolerance

    2 weeks

Secondary Outcomes (3)

  • Cow's milk protein hypersensitivity score

    2 weeks

  • Growth (weight, height, head circumference)

    3 months

  • Growth (weight, height, head circumference)

    4 months

Study Arms (1)

New Thickened Extensively Hydrolyzed formula

EXPERIMENTAL
Dietary Supplement: Extensively Hydrolyzed formula

Interventions

Extensively Hydrolyzed formulaDIETARY_SUPPLEMENT
New Thickened Extensively Hydrolyzed formula

Eligibility Criteria

Age1 Month - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • between 1 and 12 months old
  • having a cow milk allergy confirmed by a positive double-blind food challenge performed in the last 3 months,
  • whose parent(s) signed the informed consent form

You may not qualify if:

  • Infants mainly or exclusively breastfed,
  • 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 (3)

Centre Hospitalier Régional

Namur, Belgium

Location

Necker Children's Hospital

Paris, France

Location

University of Naples Federico II

Naples, Italy

Location

Related Publications (1)

  • Dupont C, Bradatan E, Soulaines P, Nocerino R, Berni-Canani R. Tolerance and growth in children with cow's milk allergy fed a thickened extensively hydrolyzed casein-based formula. BMC Pediatr. 2016 Jul 18;16:96. doi: 10.1186/s12887-016-0637-3.

    PMID: 27430981DERIVED

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Food HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2015

First Posted

January 30, 2015

Study Start

November 1, 2013

Primary Completion

December 1, 2014

Last Updated

January 30, 2015

Record last verified: 2015-01

Locations

FR(1)IT(1)BE(1)