Atopic Dermatitis Clinical Trial
Official title:
Efficacy of Fermented Rice Flour for the Treatment of Atopic Dermatitis : Randomized, Double-Blind, Placebo-Controlled Trial
This Study Evaluate the efficacy of the subministration of fermented rice flour (7 g/day) on the clinical course of patients with moderate or severe Atopic Dermatitis, in terms of a reduction in the SCORAD score, during the study period and four weeks after the suspension of the treatment.
It is scientifically recognised that some probiotic effects can be obtained from inactivated
bacteria or isolated bacterial components (e.g. bacterial DNA) or factors produced during
fermentation (short-chain fatty acids, bacterial proteins, etc.) (7). This category also
includes the ingredient which forms the focus of this trial: fermented rice flour, prepared
from rice flour fermented by a probiotic (Lactobacillus paracasei CBA L74) which was
heat-inactivated at the end of the fermentation process. The finished product, therefore,
does not contain live bacteria.
The bacterium used - owned by the sponsor and filed with the BCCM/LMG bacteria collection -
belongs to the species Lactobacillus paracasei, and is included in the Qualified Presumption
of Safety (QPS) list of microorganisms compiled by the European Food Safety Authority's Panel
on Biological Hazards (8). The bacterium has been tested for its sensitivity to antibiotics
on the basis of the relevant criteria drawn up by the EFSA (9) and its genomic sequence is
known. Pre-clinical studies have shown anti-inflammatory effects of food matrices fermented
with Lactobacillus paracasei CBA L74 (stimulating the production of IL-10 and the reduction
of IL-12), and in response to stimulation with Salmonella typhimurium (10). Recently, the
clinical effects of the consumption of rice flour fermented with Lactobacillus paracasei CBA
L74 for 12 weeks were tested in a pilot study conducted on children with moderate/severe AD
(defined using the SCORAD index) (11). In this study, all the children reported an
improvement in the severity of the AD and reduced topical steroid application frequency.
Considering the rationale for the use of live or inactivated probiotics or isolated bacterial
components for the treatment of AD as well as the clinical studies in the paediatric
population that have shown encouraging results (11), this randomised, double-blind,
placebo-controlled trial aims to evaluate the efficacy of rice flour fermented with
Lactobacillus paracasei CBA L74 in subjects with AD; in particular, this trial will evaluate
the clinical response in terms of the severity of the AD during and at the end of a 12-week
treatment period and four weeks after the suspension of the treatment.
;
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