Atopic DermatitisNCT03157284
Efficacy of Fermented Rice Flour for the Treatment of Atopic Dermatitis
A study testing Rice Flour in people with Atopic Dermatitis, run by Heinz Italia SpA at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 36 months
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Rice Flour
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteItaly
- Study dates
- 23 Jan 2017to 29 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Fermented Rice Flour for the Treatment of Atopic Dermatitis : Randomized, Double-Blind, Placebo-Controlled Trial
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.
Read the detailed description
It is scientifically recognised that some probiotic effects can be obtained from inactivated bacteria or isolated bacterial components (e.g. bacterial DNA) or factors produced during fermentation (short-chain fatty acids, bacterial proteins, etc.) (7). This category also includes the ingredient which forms the focus of this trial: fermented rice flour, prepared from rice flour fermented by a probiotic (Lactobacillus paracasei CBA L74) which was heat-inactivated at the end of the fermentation process. The finished product, therefore, does not contain live bacteria.
The bacterium used - owned by the sponsor and filed with the BCCM/LMG bacteria collection - belongs to the species Lactobacillus paracasei, and is included in the Qualified Presumption of Safety (QPS) list of microorganisms compiled by the European Food Safety Authority's Panel on Biological Hazards (8). The bacterium has been tested for its sensitivity to antibiotics on the basis of the relevant criteria drawn up by the EFSA (9) and its genomic sequence is known. Pre-clinical studies have shown anti-inflammatory effects of food matrices fermented with Lactobacillus paracasei CBA L74 (stimulating the production of IL-10 and the reduction of IL-12), and in response to stimulation with Salmonella typhimurium (10). Recently, the clinical effects of the consumption of rice flour fermented with Lactobacillus paracasei CBA L74 for 12 weeks were tested in a pilot study conducted on children with moderate/severe AD (defined using the SCORAD index) (11). In this study, all the children reported an improvement in the severity of the AD and reduced topical steroid application frequency.
Considering the rationale for the use of live or inactivated probiotics or isolated bacterial components for the treatment of AD as well as the clinical studies in the paediatric population that have shown encouraging results (11), this randomised, double-blind, placebo-controlled trial aims to evaluate the efficacy of rice flour fermented with Lactobacillus paracasei CBA L74 in subjects with AD; in particular, this trial will evaluate the clinical response in terms of the severity of the AD during and at the end of a 12-week treatment period and four weeks after the suspension of the treatment.
- Conditions
- Atopic Dermatitis
- Being tested
- Rice Flour, Placebo
- Keywords
- Lactobacillus, Probiotics
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rice FlourDietary supplement
For 12 weeks, a group of children will receive 7gr fermented rice flour according to a randomised, double-blind design.
PlaceboDietary supplement
For 12 weeks a group of children will receive a 7gr of a placebo (maltodextrin), according to a randomised, double-blind design.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Group will receive 7gr Maltodextrin Receives: Dietary Supplement: Placebo |
| Intervention Rice Flour | Experimental | The Intervention Group will receive 7gr of the experimental ingredient fermented Rice Flour Receives: Dietary Supplement: Rice Flour |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 16 weeks
Secondary outcomes (4)
Inflammatory response :Peripheral immunophenotype analysis and Cytokine profile
Evaluate the inflammatory response at baseline (T0) and at the end of treatment (T12) in terms of inflammation markers (cytokine profile) and peripheral immunophenotype compared to the placebo group.Peripheral cytokine assay (IFNγ, IL-4, IL-5, IL-10, IL-12, IL-13, IL-18, IL-31) at baseline and after specific stimulation (anti-CD3/CD28) or non-specific stimulation (PHA) on all enrolled children.
Measured: 12 weeks
Allergic sensitisation:Total and specific IgE (sIgE) assay
Evaluate allergic sensitisation by total and specific IgE (sIgE) assay at baseline (T0) and at the end of treatment (T12) compared to the placebo group
Measured: 12 weeks
Steroids prescription
Evaluate the prescription of topical steroid therapy in the group of children treated with fermented rice flour compared to the placebo group.
Measured: 16 weeks
Faecal microbiota analysis
Evaluate the change in intestinal microbial flora between T0 and T12
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start23 Jan 2017
- Primary completion24 May 2019
- Study completion29 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinz Italia SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- EnzaCarmina D'Auria, Dott, Principal investigator, Clinica Pediatrica Ospedale dei Bambini Vittore Buzzi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157284
- Sponsor's protocol ID
- FERCT16
- Status last verified
- Dec 2019
- First submitted
- 1 May 2017
- Last updated
- 18 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18408746Sidbury 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.
PubMed 25264237Isolauri 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.
PubMed 11069570Weston 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.
PubMed 15863468Majamaa 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.
PubMed 9042042Sistek 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.
PubMed 16650048Agostoni 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.
PubMed 17325568Zagato 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.
PubMed 24520333Beretta 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.
PubMed 25757084Severity 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.
PubMed 8435513Schram 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.
PubMed 21951293Rausch 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.
PubMed 12881035
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Fermented Rice Flour for the Treatment of Atopic Dermatitis : Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT03157284
- Acronym / sponsor ID
- FERCT16
- Conditions
- Atopic Dermatitis
- Keywords
- Lactobacillus, Probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Heinz Italia SpAIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2017 (actual)
- Primary completion
- 24 May 2019 (actual)
- Study completion
- 29 May 2019 (actual)
- First posted
- 17 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
It is scientifically recognised that some probiotic effects can be obtained from inactivated bacteria or isolated bacterial components (e.g. bacterial DNA) or factors produced during fermentation (short-chain fatty acids, bacterial proteins, etc.) (7). This category also includes the ingredient which forms the focus of this trial: fermented rice flour, prepared from rice flour fermented by a probiotic (Lactobacillus paracasei CBA L74) which was heat-inactivated at the end of the fermentation process. The finished product, therefore, does not contain live bacteria.
The bacterium used - owned by the sponsor and filed with the BCCM/LMG bacteria collection - belongs to the species Lactobacillus paracasei, and is included in the Qualified Presumption of Safety (QPS) list of microorganisms compiled by the European Food Safety Authority's Panel on Biological Hazards (8). The bacterium has been tested for its sensitivity to antibiotics on the basis of the relevant criteria drawn up by the EFSA (9) and its genomic sequence is known. Pre-clinical studies have shown anti-inflammatory effects of food matrices fermented with Lactobacillus paracasei CBA L74 (stimulating the production of IL-10 and the reduction of IL-12), and in response to stimulation with Salmonella typhimurium (10). Recently, the clinical effects of the consumption of rice flour fermented with Lactobacillus paracasei CBA L74 for 12 weeks were tested in a pilot study conducted on children with moderate/severe AD (defined using the SCORAD index) (11). In this study, all the children reported an improvement in the severity of the AD and reduced topical steroid application frequency.
Considering the rationale for the use of live or inactivated probiotics or isolated bacterial components for the treatment of AD as well as the clinical studies in the paediatric population that have shown encouraging results (11), this randomised, double-blind, placebo-controlled trial aims to evaluate the efficacy of rice flour fermented with Lactobacillus paracasei CBA L74 in subjects with AD; in particular, this trial will evaluate the clinical response in terms of the severity of the AD during and at the end of a 12-week treatment period and four weeks after the suspension of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo Group will receive 7gr Maltodextrin |
| Intervention Rice Flour | Experimental | Dietary Supplement: Rice FlourThe Intervention Group will receive 7gr of the experimental ingredient fermented Rice Flour |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rice FlourFor 12 weeks, a group of children will receive 7gr fermented rice flour according to a randomised, double-blind design. | Dietary supplement | Intervention Rice Flour |
| PlaceboFor 12 weeks a group of children will receive a 7gr of a placebo (maltodextrin), according to a randomised, double-blind design. | Dietary supplement | Placebo |
Primary outcome
Reduction in the SCORAD score
Time frame: 16 weeks
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
4 secondary outcomes
Inflammatory response :Peripheral immunophenotype analysis and Cytokine profile
Time frame: 12 weeks
Allergic sensitisation:Total and specific IgE (sIgE) assay
Time frame: 12 weeks
Steroids prescription
Time frame: 16 weeks
Faecal microbiota analysis
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
- Background: PubMed 18408746Elias 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.
- Background: PubMed 25264237Sidbury 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.
- Background: PubMed 11069570Isolauri 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.
- Background: PubMed 15863468Weston 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.
- Background: PubMed 9042042Majamaa 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.
- Background: PubMed 16650048Sistek 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.
- Background: PubMed 17325568Agostoni 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.
- Background: PubMed 24520333Zagato 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.
- Background: PubMed 25757084Beretta 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.
- Background: PubMed 8435513Severity 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.
- Background: PubMed 21951293Schram 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.
- Background: PubMed 12881035Rausch 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
EnzaCarmina D'Auria, Dott principal investigator
Clinica Pediatrica Ospedale dei Bambini Vittore Buzzi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rice Flour in people with Atopic Dermatitis, run by Heinz Italia SpA at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in the SCORAD score (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03157284, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2019.