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Effects of synbiotics in infants with atopic dermatitis.


- candidate number1212
- NTR NumberNTR128
- ISRCTNISRCTN69085979
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR23-aug-2005
- Secondary IDsN/A 
- Public TitleEffects of synbiotics in infants with atopic dermatitis.
- Scientific TitleEffects of synbiotics in infants with atopic dermatitis.
- ACRONYMSynbad
- hypothesisPre- 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.
- Healt Condition(s) or Problem(s) studiedAtopic Eczema Dermatitis Syndrome, AEDS
- Inclusion criteriaMain criteria:
Term infants, between 0 and 7 months of age, fulfilling standard criteria for AEDS.
- Exclusion criteriaMain criteria:
Scorad score < 15, use of anti-histamines or systemic corticosteroids or anti-mycotic drugs, Skin disorder other than AEDS.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2005
- planned closingdate31-dec-2006
- Target number of participants90
- InterventionsScorad, questionnaires on AEDS symptoms, Blood collection for safety, immunological and immunological parameters. Stool collection for faecal microbiota evaluation.
- Primary outcomeDecrease in Scorad score after 12 weeks of treatment is >25% greater in the active group compared to the placebo group.
- Secondary outcomeImmunological parameters. Faecal microbiota parameters, Quality of Life of the parents and parental stress, gastro-intestinal tract characteristics.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESPhD D.A.M. Goossens
- CONTACT for SCIENTIFIC QUERIESProf. H. Heymans
- Sponsor/Initiator Danone Research B.V.
- Funding
(Source(s) of Monetary or Material Support)
Danone Research B.V.
- PublicationsN/A
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD16-aug-2005 - 14-sep-2009


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