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

February 2, 2017 updated by: Gian Vincenzo Zuccotti, University of Milan

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SCORAD change
Time Frame: 12 weeks
The treatment will be stopped at 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SCORAD change
Time Frame: 16 weeks
The outcome will be evaluated also 4 weeks after the suspension of treatment
16 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fecal microbiota composition
Time Frame: 12 weeks
12 weeks
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
12 weeks
Peripheral immunophenotyping
Time Frame: 12 weeks
Measurement of peripheral Treg, central memory and effector and Th1/Th2/Th17 cells
12 weeks
Total and specific IgE
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milan

Investigators

  • Principal Investigator: Gian Vincenzo Zuccotti, MD, Pediatrics Department Ospedale dei Bambini V. Buzzi Milano

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2017

Primary Completion (Anticipated)

May 31, 2017

Study Completion (Anticipated)

May 31, 2017

Study Registration Dates

First Submitted

January 30, 2017

First Submitted That Met QC Criteria

February 2, 2017

First Posted (Estimate)

February 3, 2017

Study Record Updates

Last Update Posted (Estimate)

February 3, 2017

Last Update Submitted That Met QC Criteria

February 2, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FERCT16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Child

Clinical Trials on Fermented rice

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe