Condition category
Skin and Connective Tissue Diseases
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
05/11/2010
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 D.A.M. Goossens

ORCID ID

Contact details

Numico Research B.V.
P.O. Box 7005
Alkmaar
6700 CA
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

n/a

Study information

Scientific title

Acronym

Synbad

Study hypothesis

Pre- and probiotics are able to change the composition of the altered intestinal microbiota that is found in allergic patients, indicating beneficial effects of these nutritional components in the prevention and treatment of allergic diseases. The addition of a patented symbiotic mixture of prebiotics and probiotics to a standard infant formula is assumed to improve the clinical symptoms of Atopic Eczema Dermatitis Syndrome (AEDS).

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Multicentre, 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

Atopic Eczema Dermatitis Syndrome (AEDS)

Intervention

Infants will receive in a double-blind fashion either standard infant formula or infant formula with added synbiotica, for 12 weeks.

Analyses:
1. Scorad
2. Questionnaires on AEDS symptoms
3. Blood collection for safety, immunological and immunological parameters
4. Stool collection for faecal microbiota evaluation

Intervention type

Drug

Phase

Not Specified

Drug names

Prebiotics, probiotics

Primary outcome measures

Decrease in Scorad score after 12 weeks of treatment is more than 25% greater in the active group compared to the placebo group.

Secondary outcome measures

1. Immunological parameters
2. Faecal microbiota parameters
3. Quality of life of the parents and parental stress
4. Gastro-intestinal tract characteristics

Overall trial start date

01/09/2005

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Infants, between 0 and 7 months of age
2. Fulfilling standard criteria for AEDS

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

90

Participant exclusion criteria

1. Scorad score 15
2. Use of anti-histamines or systemic corticosteroids or anti-mycotic drugs
3. Skin disorder other than AEDS

Recruitment start date

01/09/2005

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Numico Research B.V.
Alkmaar
6700 CA
Netherlands

Sponsor information

Organisation

Numico Research B.V. (The Netherlands)

Sponsor details

20 Bosrand Rd
P.O. Box 7005
Wageningen
6704 PH
Netherlands

Sponsor type

Industry

Website

http://www.numico.com/en/

Funders

Funder type

Industry

Funder name

Numico Research B.V. (The 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

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20184604

Publication citations

  1. Results

    van der Aa LB, Heymans HS, van Aalderen WM, Sillevis Smitt JH, Knol J, Ben Amor K, Goossens DA, Sprikkelman AB, , Effect of a new synbiotic mixture on atopic dermatitis in infants: a randomized-controlled trial., Clin. Exp. Allergy, 2010, 40, 5, 795-804, doi: 10.1111/j.1365-2222.2010.03465.x.

Additional files

Editorial Notes