NCT01181297

Brief Summary

The purpose of this study is to confirm the hypoallergenicity of an extensively hydrolyzed formula with an added probiotic in children with documented milk allergy.

Trial Health

90
On Track

Trial Health Score

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

Timeline
Completed

Started Jan 2003

Typical duration for not_applicable

Geographic Reach
2 countries

2 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

January 1, 2003

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2010

Completed
Last Updated

August 13, 2010

Status Verified

August 1, 2010

Enrollment Period

1.8 years

First QC Date

August 12, 2010

Last Update Submit

August 12, 2010

Conditions

Allergy

Keywords

Confirmed milk allergy

Study Arms (2)

Extensively Hydrolyzed Formula with a Probiotic

EXPERIMENTAL

Extensively Hydrolyzed Formula with a Probiotic

Other: Extensively Hydrolyzed Formula with a Probiotic

Extensively Hydrolyzed Formula without a Probiotic

PLACEBO COMPARATOR
Other: Extensively Hydrolyzed Formula without a Probiotic

Interventions

Extensively Hydrolyzed Formula with a ProbioticOTHER
Extensively Hydrolyzed Formula with a Probiotic
Extensively Hydrolyzed Formula without a ProbioticOTHER
Extensively Hydrolyzed Formula without a Probiotic

Eligibility Criteria

AgeUp to 14 Years
Sexall
Age GroupsChild (0-17)

You may qualify if:

  • ≤14 years of age
  • Essentially asymptomatic for a minimum of 7 days pre-challenge.
  • Successful previous consumption of Extensively Hydrolyzed Formula within 1 week of study enrollment
  • Medically documented allergy to cow's milk

You may not qualify if:

  • Presence of underlying systemic disease or other illness
  • Used Beta-blockers within 12-24 hours of challenges
  • Use of short-acting antihistamines within 3 days
  • Use of medium-acting antihistamines within 7 days
  • Use of long-acting antihistamines within 6 weeks
  • Use of oral steroid medication within 3 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dept. of Paediatrics, Azienda Ospedaliera di Padova

Padua, Veneto, 35128, Italy

Location

Wilhelmina Children's Hospital

Utrecht, Utrecht, 3508, Netherlands

Location

Related Publications (1)

  • Muraro A, Hoekstra MO, Meijer Y, Lifschitz C, Wampler JL, Harris C, Scalabrin DM. Extensively hydrolysed casein formula supplemented with Lactobacillus rhamnosus GG maintains hypoallergenic status: randomised double-blind, placebo-controlled crossover trial. BMJ Open. 2012 Mar 5;2(2):e000637. doi: 10.1136/bmjopen-2011-000637. Print 2012.

    PMID: 22396223DERIVED

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 12, 2010

First Posted

August 13, 2010

Study Start

January 1, 2003

Primary Completion

November 1, 2004

Study Completion

November 1, 2004

Last Updated

August 13, 2010

Record last verified: 2010-08

Locations

IT(1)NL(1)