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Trial record 2 of 7 for:    8435513 [PUBMED-IDS]

Efficacy of Fermented Rice Flour for the Treatment of Atopic Dermatitis: Randomized, Double-blind Controlled Trial

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ClinicalTrials.gov Identifier: NCT03042624
Recruitment Status : Recruiting
First Posted : February 3, 2017
Last Update Posted : February 3, 2017
Sponsor:
Information provided by (Responsible Party):
Gian Vincenzo Zuccotti, University of Milan

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Child Infant Dietary Supplement: Fermented rice Dietary Supplement: Maltodextrins Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel-arm, Randomized, Double-blind Controlled Trial
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Each treatment is numbered consecutively without any reference to the underlying randomization scheme, which is known only to the statistician who generated the list and to the technician who prepared the packages. The packages and their contents are indistinguishable.
Primary Purpose: Treatment
Official Title: Efficacy of Fermented Rice Flour for the Treatment of Atopic Dermatitis: Randomized, Double-blind Controlled Trial
Actual Study Start Date : January 24, 2017
Estimated Primary Completion Date : May 31, 2017
Estimated Study Completion Date : May 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Fermented rice
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 powder obtained from Lactobacillus paracasei CBA L74

Placebo Comparator: Maltodextrins
7 g of maltodextrins powder to be diluted in milk or water
Dietary Supplement: Maltodextrins
7 g of maltodextrins powder




Primary Outcome Measures :
  1. SCORAD change [ Time Frame: 12 weeks ]
    The treatment will be stopped at 12 weeks


Secondary Outcome Measures :
  1. SCORAD change [ Time Frame: 16 weeks ]
    The outcome will be evaluated also 4 weeks after the suspension of treatment


Other Outcome Measures:
  1. Fecal microbiota composition [ Time Frame: 12 weeks ]
  2. Cytokine profiling [ Time Frame: 12 weeks ]
    Measurement of peripheral IFN-gamma, IL-4, IL-5, IL-10, IL-12, IL-13, IL-18 and IL-31

  3. Peripheral immunophenotyping [ Time Frame: 12 weeks ]
    Measurement of peripheral Treg, central memory and effector and Th1/Th2/Th17 cells

  4. Total and specific IgE [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of moderate or sever atopic dermatitis using SCORAD

Exclusion Criteria:

  • acute rhino-conjunctivitis
  • acute asthma
  • autoimmune disease
  • chronic obstructive pulmonary disease
  • heart disease
  • renal disease
  • treatment with prebiotics 1 month before the enrolment
  • treatment with probiotics 1 month before the enrolment
  • treatment with antibiotics (undergoing)
  • treatment with systemic immune-modulators 1 month before the enrolment
  • treatment with local immune-modulators 1 month before the enrolment
  • acute or chronic infectious disease
  • known hypersensitivity to components of fermented rice flour

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03042624


Contacts
Contact: Enza Carmina D'Auria, MD, PhD mailto:enzacarmina.dauria@asst-fbf-sacco.it

Locations
Italy
Pediatrics Department Ospedale dei Bambini V. Buzzi Recruiting
Milano, Italy, 20154
Contact: Enza Carmina D'Auria, MD, PhD       mailto:enzacarmina.dauria@asst-fbf-sacco.it   
Sponsors and Collaborators
University of Milan
Investigators
Principal Investigator: Gian Vincenzo Zuccotti, MD Pediatrics Department Ospedale dei Bambini V. Buzzi Milano

Publications:

Responsible Party: Gian Vincenzo Zuccotti, Professor of Pediatrics, University of Milan
ClinicalTrials.gov Identifier: NCT03042624     History of Changes
Other Study ID Numbers: FERCT16
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases