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

NCT03042624 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-02-03

No results posted yet for this study

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.

Conditions

  • Dermatitis, Atopic
  • Child
  • Infant

Interventions

DIETARY_SUPPLEMENT

Fermented rice

7 g of powder obtained from Lactobacillus paracasei CBA L74

DIETARY_SUPPLEMENT

Maltodextrins

7 g of maltodextrins powder

Sponsors & Collaborators

  • University of Milan

    lead OTHER

Principal Investigators

  • Gian Vincenzo Zuccotti, MD · Pediatrics Department Ospedale dei Bambini V. Buzzi Milano

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-24
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03042624 on ClinicalTrials.gov