Pilot study: probiotics in children with atopic dermatitis and food allergy - is there an in vivo or in vitro effect on the immunological response?

ISRCTN	ISRCTN28834761
DOI	https://doi.org/10.1186/ISRCTN28834761
Protocol serial number	NTR127
Sponsor	Winclove BioIndustries BV (Netherlands)
Funder	Winclove BioIndustries BV (Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr E. Hoffen, van
Scientific

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

Primary study design	Interventional
Study design	Randomised, double blinded, placebo controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Treatment with probiotics can alter the allergen-specific in vivo or in vitro immunological response in food-allergic children.
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Probiotics
Primary outcome measure(s)	1. Allergen-specific T-cell response, B cell response.
Key secondary outcome measure(s)	1. SCORing Atopic Dermatitis (SCORAD) 2. Immunoglobulin E Radioallergosorbent Test (IgE RAST) 3. Skin Prick Test (SPT)
Completion date	01/03/2005

Participant type(s)	Patient
Age group	Child
Lower age limit	0 Years
Upper age limit	3 Years
Sex	All
Target sample size at registration	13
Key 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
Key exclusion criteria	1. Other systemic diseases 2. Immunocompromised 3. Systemic treatment with immunomodulating drugs
Date of first enrolment	01/03/2003
Date of final enrolment	01/03/2005

Dep. Dermatology/Allergology (G02.124)

Utrecht
3508 GA
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2007		Yes	No