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

NCT03042624 | Unknown

• 1 other identifier: FERCT16
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermatitis, Atopic; Child; Infant

Outcome Measures

Primary Outcomes (1)

• SCORAD change

  The treatment will be stopped at 12 weeks

  12 weeks

Secondary Outcomes (1)

• SCORAD change

  16 weeks

Other Outcomes (4)

• Fecal microbiota composition

  12 weeks

• Cytokine profiling

  12 weeks

• Peripheral immunophenotyping

  12 weeks

Study Arms (2)

Fermented rice

EXPERIMENTAL

7 g of fermented rice flour powder obtained from Lactobacillus paracasei CBA L74 to be diluted in milk or water

Dietary Supplement: Fermented rice

Maltodextrins

PLACEBO COMPARATOR

7 g of maltodextrins powder to be diluted in milk or water

Dietary Supplement: Maltodextrins

Interventions

Fermented rice DIETARY_SUPPLEMENT

7 g of powder obtained from Lactobacillus paracasei CBA L74

Fermented rice

Maltodextrins DIETARY_SUPPLEMENT

7 g of maltodextrins powder

Maltodextrins

Eligibility Criteria

• Age: 6 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• diagnosis of moderate or sever atopic dermatitis using SCORAD

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

Pediatrics Department Ospedale dei Bambini V. Buzzi

Milan, 20154, Italy

RECRUITING

Related Publications (9)

• Elias PM, Steinhoff M. "Outside-to-inside" (and now back to "outside") pathogenic mechanisms in atopic dermatitis. J Invest Dermatol. 2008 May;128(5):1067-70. doi: 10.1038/jid.2008.88.

  PMID: 18408746 BACKGROUND

• Majamaa H, Isolauri E. Probiotics: a novel approach in the management of food allergy. J Allergy Clin Immunol. 1997 Feb;99(2):179-85. doi: 10.1016/s0091-6749(97)70093-9.

  PMID: 9042042 BACKGROUND

• Isolauri E, Arvola T, Sutas Y, Moilanen E, Salminen S. Probiotics in the management of atopic eczema. Clin Exp Allergy. 2000 Nov;30(11):1604-10. doi: 10.1046/j.1365-2222.2000.00943.x.

  PMID: 11069570 BACKGROUND

• Weston S, Halbert A, Richmond P, Prescott SL. Effects of probiotics on atopic dermatitis: a randomised controlled trial. Arch Dis Child. 2005 Sep;90(9):892-7. doi: 10.1136/adc.2004.060673. Epub 2005 Apr 29.

  PMID: 15863468 BACKGROUND

• Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology. 1993;186(1):23-31. doi: 10.1159/000247298.

  PMID: 8435513 BACKGROUND

• Agostoni C, Goulet O, Kolacek S, Koletzko B, Moreno L, Puntis J, Rigo J, Shamir R, Szajewska H, Turck D; ESPGHAN Committee on Nutrition. Fermented infant formulae without live bacteria. J Pediatr Gastroenterol Nutr. 2007 Mar;44(3):392-7. doi: 10.1097/01.mpg.0000258887.93866.69.

  PMID: 17325568 BACKGROUND

• Zagato E, Mileti E, Massimiliano L, Fasano F, Budelli A, Penna G, Rescigno M. Lactobacillus paracasei CBA L74 metabolic products and fermented milk for infant formula have anti-inflammatory activity on dendritic cells in vitro and protective effects against colitis and an enteric pathogen in vivo. PLoS One. 2014 Feb 10;9(2):e87615. doi: 10.1371/journal.pone.0087615. eCollection 2014.

  PMID: 24520333 BACKGROUND

• Beretta S, Fabiano V, Petruzzi M, Budelli A, Zuccotti GV. Fermented rice flour in pediatric atopic dermatitis. Dermatitis. 2015 Mar-Apr;26(2):104-6. doi: 10.1097/DER.0000000000000103. No abstract available.

  PMID: 25757084 BACKGROUND

• Schram ME, Spuls PI, Leeflang MM, Lindeboom R, Bos JD, Schmitt J. EASI, (objective) SCORAD and POEM for atopic eczema: responsiveness and minimal clinically important difference. Allergy. 2012 Jan;67(1):99-106. doi: 10.1111/j.1398-9995.2011.02719.x. Epub 2011 Sep 27.

  PMID: 21951293 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Gian Vincenzo Zuccotti, MD

  Pediatrics Department Ospedale dei Bambini V. Buzzi Milano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enza Carmina D'Auria, MD, PhD

CONTACT

mailto:enzacarmina.dauria@asst-fbf-sacco.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Model Details: Parallel-arm, Randomized, Double-blind Controlled Trial

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 3, 2017
• Study Start: January 24, 2017
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2017
• Last Updated: February 3, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)