NCT03157284

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 23, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 17, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2019

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2019

Completed
Last Updated

December 18, 2019

Status Verified

December 1, 2019

Enrollment Period

2.3 years

First QC Date

May 1, 2017

Last Update Submit

December 17, 2019

Conditions

Atopic Dermatitis

Keywords

Lactobacillus, Probiotics

Outcome Measures

Primary Outcomes (1)

  • Reduction in the SCORAD score

    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

    16 weeks

Secondary Outcomes (4)

  • Inflammatory response :Peripheral immunophenotype analysis and Cytokine profile

    12 weeks

  • Allergic sensitisation:Total and specific IgE (sIgE) assay

    12 weeks

  • Steroids prescription

    16 weeks

  • Faecal microbiota analysis

    12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo Group will receive 7gr Maltodextrin

Dietary Supplement: Placebo

Intervention Rice Flour

EXPERIMENTAL

The Intervention Group will receive 7gr of the experimental ingredient fermented Rice Flour

Dietary Supplement: Rice Flour

Interventions

Rice FlourDIETARY_SUPPLEMENT

For 12 weeks, a group of children will receive 7gr fermented rice flour according to a randomised, double-blind design.

Intervention Rice Flour
PlaceboDIETARY_SUPPLEMENT

For 12 weeks a group of children will receive a 7gr of a placebo (maltodextrin), according to a randomised, double-blind design.

Placebo

Eligibility Criteria

Age6 Months - 36 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale dei Bambini Vittore Buzzi-Clinica Pediatrica

Milan, Italy

Location

Related Publications (12)

  • 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: 18408746BACKGROUND

  • Sidbury R, Tom WL, Bergman JN, Cooper KD, Silverman RA, Berger TG, Chamlin SL, Cohen DE, Cordoro KM, Davis DM, Feldman SR, Hanifin JM, Krol A, Margolis DJ, Paller AS, Schwarzenberger K, Simpson EL, Williams HC, Elmets CA, Block J, Harrod CG, Smith Begolka W, Eichenfield LF. Guidelines of care for the management of atopic dermatitis: Section 4. Prevention of disease flares and use of adjunctive therapies and approaches. J Am Acad Dermatol. 2014 Dec;71(6):1218-33. doi: 10.1016/j.jaad.2014.08.038. Epub 2014 Sep 26.

    PMID: 25264237BACKGROUND

  • 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: 11069570BACKGROUND

  • 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: 15863468BACKGROUND

  • 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: 9042042BACKGROUND

  • Sistek D, Kelly R, Wickens K, Stanley T, Fitzharris P, Crane J. Is the effect of probiotics on atopic dermatitis confined to food sensitized children? Clin Exp Allergy. 2006 May;36(5):629-33. doi: 10.1111/j.1365-2222.2006.02485.x.

    PMID: 16650048BACKGROUND

  • 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: 17325568BACKGROUND

  • 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: 24520333BACKGROUND

  • 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: 25757084BACKGROUND

  • 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: 8435513BACKGROUND

  • 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: 21951293BACKGROUND

  • Rausch JR, Maxwell SE, Kelley K. Analytic methods for questions pertaining to a randomized pretest, posttest, follow-up design. J Clin Child Adolesc Psychol. 2003 Sep;32(3):467-86. doi: 10.1207/S15374424JCCP3203_15.

    PMID: 12881035BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Flour

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • EnzaCarmina D'Auria, Dott

    Clinica Pediatrica Ospedale dei Bambini Vittore Buzzi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2017

First Posted

May 17, 2017

Study Start

January 23, 2017

Primary Completion

May 24, 2019

Study Completion

May 29, 2019

Last Updated

December 18, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)