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Efficacy of Fermented Rice Flour for the Treatment of Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03157284
Recruitment Status : Completed
First Posted : May 17, 2017
Last Update Posted : December 18, 2019
Sponsor:
Information provided by (Responsible Party):
Heinz Italia SpA

Tracking Information
First Submitted Date  ICMJE May 1, 2017
First Posted Date  ICMJE May 17, 2017
Last Update Posted Date December 18, 2019
Actual Study Start Date  ICMJE January 23, 2017
Actual Primary Completion Date May 24, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2017)
Reduction in the SCORAD score [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2017)
  • Inflammatory response :Peripheral immunophenotype analysis and Cytokine profile [ Time Frame: 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.
  • Allergic sensitisation:Total and specific IgE (sIgE) assay [ Time Frame: 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
  • Steroids prescription [ Time Frame: 16 weeks ]
    Evaluate the prescription of topical steroid therapy in the group of children treated with fermented rice flour compared to the placebo group.
  • Faecal microbiota analysis [ Time Frame: 12 weeks ]
    Evaluate the change in intestinal microbial flora between T0 and T12
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Fermented Rice Flour for the Treatment of Atopic Dermatitis
Official Title  ICMJE Efficacy of Fermented Rice Flour for the Treatment of Atopic Dermatitis : Randomized, Double-Blind, Placebo-Controlled Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE
  • Dietary Supplement: Rice Flour
    For 12 weeks, a group of children will receive 7gr fermented rice flour according to a randomised, double-blind design.
  • Dietary Supplement: Placebo
    For 12 weeks a group of children will receive a 7gr of a placebo (maltodextrin), according to a randomised, double-blind design.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo Group will receive 7gr Maltodextrin
    Intervention: Dietary Supplement: Placebo
  • Experimental: Intervention Rice Flour
    The Intervention Group will receive 7gr of the experimental ingredient fermented Rice Flour
    Intervention: Dietary Supplement: Rice Flour
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 17, 2019)
58
Original Estimated Enrollment  ICMJE
 (submitted: May 16, 2017)
56
Actual Study Completion Date  ICMJE May 29, 2019
Actual Primary Completion Date May 24, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 36 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03157284
Other Study ID Numbers  ICMJE FERCT16
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Heinz Italia SpA
Study Sponsor  ICMJE Heinz Italia SpA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: EnzaCarmina D'Auria, Dott Clinica Pediatrica Ospedale dei Bambini Vittore Buzzi
PRS Account Heinz Italia SpA
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP