No registrations found.
ID
Source
Brief title
Health condition
Atopic Eczema Dermatitis Syndrome
Sponsors and support
Wageningen, the Netherlands
Dr. A. Vriesema
(+31) 317-467800
Intervention
Outcome measures
Primary outcome
Decrease in Scorad score after 12 weeks of treatment is >25% greater in the active group compared to the placebo group.
Secondary outcome
Immunological parameters. Faecal microbiota parameters, Quality of Life of the parents and parental stress, gastro-intestinal tract characteristics.
Background summary
The effect of synbiotics added to a standard infant formula will be evaluated in infants (0-7months of age) on their AEDS symptoms. Infants will receive in a double-blind fashion either standard infant formula or infant formula with added synbiotica, for 12 weeks.
Study objective
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 synbiotic mixture of prebiotics and probiotics to a standard infant formula is assumed to improve the clinical symptoms of AEDS.
Study design
N/A
Intervention
Scorad, questionnaires on AEDS symptoms, Blood collection for safety, immunological and immunological parameters.
Stool collection for faecal microbiota evaluation.
Alkmaar
The Netherlands
+31 317 467 800 (direct line: +31 317 467 805).
Dominique.Goossens@numico-research.nl
Alkmaar
The Netherlands
+31 317 467 800 (direct line: +31 317 467 805).
Dominique.Goossens@numico-research.nl
Inclusion criteria
Main criteria:
Term infants, between 0 and 7 months of age, fulfilling standard criteria for AEDS.
Exclusion criteria
Main criteria:
Scorad score < 15,
use of anti-histamines or systemic corticosteroids or anti-mycotic drugs,
Skin disorder other than AEDS.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL97 |
| NTR-old | NTR128 |
| Other | : N/A |
| ISRCTN | ISRCTN69085979 |