An interventional study of Fermented rice and Maltodextrins in Dermatitis, Atopic, Child and Infant, sponsored by University of Milan. Status unknown at 1 site in Italy. Open to participants aged 6 Months to 36 Months. Per ClinicalTrials.gov, last updated 2017-02-03.
Sponsored by University of Milan · Not applicable, Interventional, and Treatment
This trial aims at evaluating the efficacy of a fermented rice flour for the treatment of atopic dermatitis (AD).
The fermented rice flour, obtained from Lactobacillus paracasei CBA L74 (Heinz Italia SpA, Latina, Italy), does not contain live bacteria. Lactobacillus paracasei CBA L74 belongs to the list of microorganisms with qualified presumption of safety compiled by the European Food Safety Authority (EFSA), is tested for the absence of antibiotic resistance genes in accordance with EFSA, and is genetically characterized by repetitive extragenic palindromic polymerase chain reaction.
Using a repeated-measure cohort design, the investigators have recently shown that the administration of a fermented-rice flour obtained from Lactobacillus paracasei CBA L74 was associated with a decrease of the score for atopic dermatitis (SCORAD) in children with AD.
The present randomized, double-blind, controlled trial is aimed at testing whether the fermented rice flour obtained from Lactobacillus paracasei CBA L74 is effective in reducing SCORAD in children with moderate to severe AD using placebo as comparator.
Atopic dermatitis (AD), an itchy eczema with a chronic relapsing course, is the most common clinical manifestation of atopy in the first years of life.
On the basis of the available knowledge, AD is produced by an alteration of the skin barrier which triggers an inflammatory reaction. Such reaction is characterized by an early phase with abundance of Th2 cytokines (IL-4, IL-5) and eosinophils and by a later phase with predominance of Th1 cytokines (IL-2, IL-12 and IFN-gamma).
Emollients, possibly supplemented with ceramides, represent the first step of the treatment of AD. Corticosteroids are the most effective topical drugs. The use of topical immune-modulators (tacrolimus and pimecrolimus) offers an alternative to steroid therapy for long-term treatments. Severe cases require systemic therapy with steroids and cyclosporine and phototherapy with narrowband ultraviolet (UVB) and psoralen-ultraviolet A (PUVA) phototherapy.
The use of probiotics for the treatment of AD has attracted much interest in recent years but the available data are not conclusive. Probiotic-like effects can be obtained from inactivated bacteria or isolated bacterial components so that an extensive definition of probiotics has been proposed as bacterial cells or bacterial components that have a beneficial impact on the health and well-being of guests.
Using a repeated-measure cohort design, the investigators have recently shown that the administration of the fermented-rice flour obtained from Lactobacillus paracasei CBA L74 was associated with a decrease of SCORAD (score for atopic dermatitis) in children with AD.
SCORAD is the most commonly employed indicator of AD activity and its minimal clinically important difference is known, making it a suitable metric for clinical trials.
The fermented rice flour, obtained from Lactobacillus paracasei CBA L74 (Heinz Italia SpA, Latina, Italy), does not contain live bacteria. Lactobacillus paracasei CBA L74 belongs to the list of microorganisms with qualified presumption of safety compiled by the European Food Safety Authority (EFSA), is tested for the absence of antibiotic resistance genes in accordance with EFSA, and is genetically characterized by repetitive extragenic palindromic polymerase chain reaction.
Pre-clinical studies have shown anti-inflammatory effects of matrices fermented with Lactobacillus paracasei CBA-L74 in terms of production of IL-10 and reduction of IL-12 in response to bacterial stimulation. Such pre-clinical data were obtained on dendritic cells, on intestinal biopsies and on murine models.
The present randomized, double-blind, controlled trial is aimed at testing whether the fermented rice flour obtained from Lactobacillus paracasei CBA L74 is effective in reducing SCORAD in children with moderate to severe AD using placebo as comparator.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's planned enrollment of 50 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →University of Milan is the lead sponsor of 177 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
7 g of fermented rice flour powder obtained from Lactobacillus paracasei CBA L74 to be diluted in milk or water
Dietary Supplement: Fermented rice
7 g of maltodextrins powder to be diluted in milk or water
Dietary Supplement: Maltodextrins
7 g of powder obtained from Lactobacillus paracasei CBA L74
7 g of maltodextrins powder
SCORAD change
The treatment will be stopped at 12 weeks
Time frame: 12 weeks
SCORAD change
The outcome will be evaluated also 4 weeks after the suspension of treatment
Time frame: 16 weeks
Fecal microbiota composition
Time frame: 12 weeks
Cytokine profiling
Measurement of peripheral IFN-gamma, IL-4, IL-5, IL-10, IL-12, IL-13, IL-18 and IL-31
Time frame: 12 weeks
Peripheral immunophenotyping
Measurement of peripheral Treg, central memory and effector and Th1/Th2/Th17 cells
Time frame: 12 weeks
Total and specific IgE
Time frame: 12 weeks
Plan to share: No
This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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University of Milan