Effects of synbiotics in infants with atopic dermatitis
| ISRCTN | ISRCTN69085979 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69085979 |
| Secondary identifying numbers | n/a |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 05/11/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr D.A.M. Goossens
Scientific
Scientific
Numico Research B.V.
P.O. Box 7005
Alkmaar
6700 CA
Netherlands
Study information
| Study design | Multicentre, randomised, double blinded, placebo controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | Synbad |
| Study objectives | 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(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Prebiotics, probiotics |
| Primary outcome measure | 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 study start date | 01/09/2005 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 0 Years |
| Upper age limit | 7 Months |
| Sex | Both |
| Target number of participants | 90 |
| Key inclusion criteria | 1. Infants, between 0 and 7 months of age 2. Fulfilling standard criteria for AEDS |
| Key exclusion criteria | 1. Scorad score 15 2. Use of anti-histamines or systemic corticosteroids or anti-mycotic drugs 3. Skin disorder other than AEDS |
| Date of first enrolment | 01/09/2005 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Numico Research B.V.
Alkmaar
6700 CA
Netherlands
6700 CA
Netherlands
Sponsor information
Numico Research B.V. (The Netherlands)
Industry
Industry
20 Bosrand Rd
P.O. Box 7005
Wageningen
6704 PH
Netherlands
| Website | http://www.numico.com/en/ |
|---|---|
"ROR" |
https://ror.org/00aj77a24 |
Funders
Funder type
Industry
Numico Research B.V. (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2010 | Yes | No |
