Efficacy of Fermented Rice Flour for the Treatment of Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Rice Flour
- Registration Number
- NCT03157284
- Lead Sponsor
- Heinz Italia SpA
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
- Children between 6 and 36 months old, gradually enrolled from among patients attending the Paediatric Dermatology and Allergy Clinic
- Diagnosis of moderate or severe Atopic Dermatitis, evaluated using the SCORAD index
- Rhinitis and/or acute asthma
- Chronic diseases (autoimmune diseases, Cronic Obstructive Pulmunary Disease, heart disease, Congenital Nephrotic diseases, diabetes, acquired or congenital immunodeficiency)
- Treatment with prebiotics and/or probiotics in the month prior to enrolment
- Ongoing antibiotic therapy
- Treatment with systemic immunomodulators in the month prior to enrolment
- Treatment with topical immunomodulators (tacrolimus or pimecrolimus) in the three months prior to enrolment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo Group will receive 7gr Maltodextrin Intervention Rice Flour Rice Flour The Intervention Group will receive 7gr of the experimental ingredient fermented Rice Flour
- Primary Outcome Measures
Name Time Method Reduction in the SCORAD score 16 weeks Standardised questionnaire for calculating the SCORAD score:
Evaluate the efficacy of the administration 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
- Secondary Outcome Measures
Name Time Method Allergic sensitisation:Total and specific IgE (sIgE) assay 12 weeks Evaluate allergic sensitisation by total and specific IgE (sIgE) assay at baseline (T0) and at the end of treatment (T12) compared to the placebo group
Inflammatory response :Peripheral immunophenotype analysis and Cytokine profile 12 weeks Evaluate the inflammatory response at baseline (T0) and at the end of treatment (T12) in terms of inflammation markers (cytokine profile) and peripheral immunophenotype compared to the placebo group.Peripheral cytokine assay (IFNγ, IL-4, IL-5, IL-10, IL-12, IL-13, IL-18, IL-31) at baseline and after specific stimulation (anti-CD3/CD28) or non-specific stimulation (PHA) on all enrolled children.
Faecal microbiota analysis 12 weeks Evaluate the change in intestinal microbial flora between T0 and T12
Steroids prescription 16 weeks Evaluate the prescription of topical steroid therapy in the group of children treated with fermented rice flour compared to the placebo group.
Trial Locations
- Locations (1)
Ospedale dei Bambini Vittore Buzzi-Clinica Pediatrica
🇮🇹Milano, Italy