Condition category
Skin and Connective Tissue Diseases
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
06/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr E. Hoffen, van

ORCID ID

Contact details

Dep. Dermatology/Allergology (G02.124)
University Medical Center Utrecht
PO Box 85.500
Utrecht
3508 GA
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR127

Study information

Scientific title

Acronym

Study hypothesis

Treatment with probiotics can alter the allergen-specific in vivo or in vitro immunological response in food-allergic children.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised, double blinded, placebo controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Food allergy, atopic dermatitis

Intervention

Active group: 3 months treatment with a daily dose of a mixture of probiotics
Placebo group: 3 months treatment with a daily dose of placebo

Intervention type

Drug

Phase

Not Specified

Drug names

Probiotics

Primary outcome measures

1. Allergen-specific T-cell response, B cell response.

Secondary outcome measures

1. SCORing Atopic Dermatitis (SCORAD)
2. Immunoglobulin E Radioallergosorbent Test (IgE RAST)
3. Skin Prick Test (SPT)

Overall trial start date

01/03/2003

Overall trial end date

01/03/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. 0 - 3 years of age
2. Atopic dermatitis
3. History strongly suggestive of food allergy or positive placebo-controlled food challenge
4. Immunoglobulin E Radioallergosorbent Test (IgE RAST) greater than or equal to 0.7 kU/l for at least two food allergens
5. Skin Prick Test (SPT) greater than or equal to 2+ for at least two food allergens

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

13

Participant exclusion criteria

1. Other systemic diseases
2. Immunocompromised
3. Systemic treatment with immunomodulating drugs

Recruitment start date

01/03/2003

Recruitment end date

01/03/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

Dep. Dermatology/Allergology (G02.124)
Utrecht
3508 GA
Netherlands

Sponsor information

Organisation

Winclove BioIndustries BV (Netherlands)

Sponsor details

Papaverweg 36-B
P.O. Box 37239
Amsterdam
1030 AE
Netherlands

Sponsor type

Industry

Website

http://www.winclove.nl/

Funders

Funder type

Industry

Funder name

Winclove BioIndustries BV (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17290150

Publication citations

  1. Results

    Flinterman AE, Knol EF, van Ieperen-van Dijk AG, Timmerman HM, Knulst AC, Bruijnzeel-Koomen CA, Pasmans SG, van Hoffen E, Probiotics have a different immunomodulatory potential in vitro versus ex vivo upon oral administration in children with food allergy., Int. Arch. Allergy Immunol., 2007, 143, 3, 237-244, doi: 10.1159/000099467.

Additional files

Editorial Notes