Dermatitis, AtopicNCT03042624
Efficacy of Fermented Rice Flour for the Treatment of Atopic Dermatitis: Randomized, Double-blind Controlled Trial
A study testing Fermented rice and Maltodextrins in people with Dermatitis, Atopic and Child, run by University of Milan at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 36 months
- Conditions the study is for
- Dermatitis, Atopic, Child, Infant
- What is being tested?
- Fermented rice and Maltodextrins
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 24 Jan 2017to 31 May 2017
- 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
- diagnosis of moderate or sever atopic dermatitis using SCORAD
Who cannot join
- acute rhino-conjunctivitis
- acute asthma
- autoimmune disease
- chronic obstructive pulmonary disease
- heart disease
- renal disease
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Enza Carmina D'Auria, MD, PhD contact
Italy1 site, 1 recruiting
- Recruiting
Pediatrics Department Ospedale dei Bambini V. Buzzi
Milan, 20154
Enza Carmina D'Auria, MD, PhD, mailto:enzacarmina.dauria@asst-fbf-sacco.it
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Dermatitis, Atopic, Child, Infant
- Being tested
- Fermented rice, Maltodextrins
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fermented riceDietary supplement
7 g of powder obtained from Lactobacillus paracasei CBA L74
MaltodextrinsDietary supplement
7 g of maltodextrins powder
| Study group | Role | What they receive |
|---|---|---|
| Fermented rice | Experimental | 7 g of fermented rice flour powder obtained from Lactobacillus paracasei CBA L74 to be diluted in milk or water Receives: Dietary Supplement: Fermented rice |
| Maltodextrins | Placebo comparator | 7 g of maltodextrins powder to be diluted in milk or water Receives: Dietary Supplement: Maltodextrins |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCORAD change
The treatment will be stopped at 12 weeks
Measured: 12 weeks
Secondary outcomes (1)
SCORAD change
The outcome will be evaluated also 4 weeks after the suspension of treatment
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start24 Jan 2017
- Primary completion31 May 2017 (estimated)
- Study completion31 May 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Dermatitis, AtopicStudies 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
- Parallel groups
- Model description
- Parallel-arm, Randomized, Double-blind Controlled Trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gian Vincenzo Zuccotti, University of Milan
- Investigators
- Gian Vincenzo Zuccotti, MD, Principal investigator, Pediatrics Department Ospedale dei Bambini V. Buzzi Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042624
- Sponsor's protocol ID
- FERCT16
- Status last verified
- Feb 2017
- First submitted
- 30 Jan 2017
- Last updated
- 3 Feb 2017
- 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 18408746Majamaa 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 9042042Isolauri 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 15863468Severity 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 8435513Agostoni 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 25757084Schram 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 21951293
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. 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 Controlled Trial
- ClinicalTrials.gov ID
- NCT03042624
- Acronym / sponsor ID
- FERCT16
- Conditions
- Dermatitis, Atopic, Child, Infant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 24 Jan 2017 (actual)
- Primary completion
- 31 May 2017 (estimated)
- Study completion
- 31 May 2017 (estimated)
- First posted
- 3 Feb 2017 (estimated)
- 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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel-arm, Randomized, Double-blind Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Fermented rice | Experimental | Dietary Supplement: Fermented rice7 g of fermented rice flour powder obtained from Lactobacillus paracasei CBA L74 to be diluted in milk or water |
| Maltodextrins | Placebo comparator | Dietary Supplement: Maltodextrins7 g of maltodextrins powder to be diluted in milk or water |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- diagnosis of moderate or sever atopic dermatitis using SCORAD
Key exclusion criteria (13 listed)
- acute rhino-conjunctivitis
- acute asthma
- autoimmune disease
- chronic obstructive pulmonary disease
- heart disease
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 |
|---|---|---|
| Fermented rice7 g of powder obtained from Lactobacillus paracasei CBA L74 | Dietary supplement | Fermented rice |
| Maltodextrins7 g of maltodextrins powder | Dietary supplement | Maltodextrins |
Primary outcome
SCORAD change
Time frame: 12 weeks
The treatment will be stopped at 12 weeks
1 secondary outcome
SCORAD change
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
- 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 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 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 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 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 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.
- 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.
Enza Carmina D'Auria, MD, PhD contact
Gian Vincenzo Zuccotti, MD principal investigator
Pediatrics Department Ospedale dei Bambini V. Buzzi Milano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fermented rice and Maltodextrins in people with Dermatitis, Atopic and Child, run by University of Milan 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 1 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 3 Feb 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Enza Carmina D'Auria, MD, PhD (mailto:enzacarmina.dauria@asst-fbf-sacco.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCORAD change (time frame: 12 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 NCT03042624, which also lists 9 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 3 Feb 2017.