A Phase 3 interventional study of Ecologic ® Panda II and placebo in Eczema and Atopic Dermatitis, sponsored by Agentschap NL. Withdrawn at 1 site in Netherlands. Open to participants aged 1 Day to 15 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-01-12.
Sponsored by Agentschap NL · Phase 3, Interventional, and Treatment
To investigate the therapeutic effect of a selected probiotic mixture on the severity of AD in infants aged 0-15 months. The probiotic mixture has been studied in laboratory setting and has proven IL-10 stimulating effects. Therefore it is thought to decrease AD severity in young children (beyond the conventional treatment).
Atopic dermatitis (AD) is a highly prevalent chronic, itching, inflammatory skin disease that often presents in infancy. The disease can be the first manifestation of the so-called atopic march, the natural progression of allergic disorders, with subsequent development of asthma and allergic rhinitis. Approximately 40% of the children with AD will develop asthma later in childhood.
Currently, topical corticosteroids are the mainstay treatment of atopic dermatitis; however, relapses are common and parents often fear possible side-effects, leading to non-compliance. There is increasing evidence that the intestinal microbiota plays an important role in the development of allergic diseases. Modulation of the intestinal microbiota with probiotics, living micro-organisms with immunomodulatory effects, could possibly offer a new way of treatment of allergic disease.
Clinical trials investigating the preventive as well as therapeutic effect of probiotics on atopic dermatitis show inconsistent results. Systematic (Cochrane) reviews of all clinical trials (about treatment of AD by use of probiotics) concluded that the probiotic strains studied to date are not an effective treatment for AD; however, there is great heterogeneity between studies since many different probiotic strains are used. Because of the known strain specific capacity in immunomodulatory effects, some strains might have a greater effect than others.
Better results can possibly be achieved by using a selected, (in laboratory setting) proven modulatory multispecies probiotic mixture, containing 6 different strains.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
Browse Dermatitis, Atopic studies →Agentschap NL is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
participants daily ingest a selected probiotic mixture for a period of 3 months
Dietary Supplement: Ecologic ® Panda II
controls daily ingest a placebo mixture for a period of 3 months.
Dietary Supplement: placebo
Probiotic strains: 3 Bifidobacteria, 3 Lactococci, 1\*10\^9 Colony Forming Units/g. Composition: rice starch, maltodextrins, bacterial strains and mix of minerals.
Also known as: multispecies probiotic mixture
rice starch, maltodextrins, and mix of minerals. The placebo mixture is similar in aspect, consistency and taste as Ecologic ® Panda II (intervention).
Also known as: placebo mixture
decrease in severity of atopic dermatitis
The primary outcome will be measured by change in the severity of AD by using the SCORAD score. Other outcomes: subjective (parental) change in eczema severity, change in amount of and type of topical steroid use, quality of life during and after intervention (measured by ITQOL questionnaire), amount of respiratory tract infections, use of antibiotics, use of primary care medicine (general practitioner). All used probiotic strains contain the QPS status. (serious) adverse events will be recorded systematically.
Time frame: 6 months
Effects on infant gut microbiota
Analyses will be done by molecular microbiological techniques on feces samples (that will be collected at baseline, and after 1,3 and 6 months after enrollment.
Time frame: 6 months
Effects on the immature immune system
These effects will be measured by analyzing serum IgE and different (Th1/Th2) cytokines and chemokines
Time frame: 6 months
This study is withdrawn, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Agentschap NL