Atopic DermatitisPhase 4NCT02519556
Trial on Effectiveness Combined Probiotics in Atopic Dermatitis in Children
A Phase 4 study testing Probiatop in people with Atopic Dermatitis, run by Casa Espirita Terra de Ismael at 1 site in Brazil.
Trial summary
Atopic dermatitis (AD) is an immune disorder, characterized by chronic skin inflammation or relapsing, whose prevalence is increasing worldwide. Its exact etiology remains unknown. Read more about this study
- Who is it for?
- Ages 6 months to 19 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Probiatop
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2015to Aug 2016
- Phase
- Phase 4
- 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 months to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinical diagnosis of Atopic Dermatitis
- Children over 6 months.
- Teens lower than 19 years
- No inclusion / Exclusion Criteria:
- Diagnostic presence or clinical signs suggesting acute or chronic skin diseases, as well as pertinent to the study, which may affect the outcome of the research.
- Being in use of drugs that can affect systemically in the course of the disease, such as systemic corticosteroids and immunosuppressants, for at least 30 days.
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- Allergy or severe adverse reactions attributable to the administration of the probiotic.
- Non adherence to treatment (ie not present regular use, as prescribed) for at least one continuous month.
- Lack of attendance by more than 50% of ratings (clinical and/or laboratory) to be held during the search.
- Patient's request (or responsible's request)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas FMRP-USP
Ribeirão Preto, São Paulo, 14048-900
About this study
Official title: Randomized, Double Blind, Controlled Trial on Effectiveness Combined Probiotics in the Treatment of Atopic Dermatitis in Children
Atopic dermatitis (AD) is an immune disorder, characterized by chronic skin inflammation or relapsing, whose prevalence is increasing worldwide. Its exact etiology remains unknown. The hypothesis that an appropriate early stimulation of the intestinal flora contributes to the establishment of the immune system balance has led to the use of probiotics in the prevention and treatment of AD in several clinical and experimental studies.
Therefore, the objectives of this study will evaluate the clinical efficacy of the mixture of probiotics (Lactobacillus and Bifidobacterium) in children with AD through the SCORAD (scoring atopic dermatitis) and to evaluate the effects of this medication in the following laboratory parameters: skin prick test, total serum immunoglobulin E (IgE), inflammation composite (interferon gamma [ɣ - IFN], interleukins [IL1-β, IL-4, IL-6, IL-8] and tumor necrosis factor alpha) and immune tolerance composite (IL-10, IL-17 and transforming growth factor beta [TGF - β]).
- Conditions
- Atopic Dermatitis
- Being tested
- Probiatop, Placebo
- Keywords
- Probiotics, Inflammation, Awareness, Immune tolerance
- Medical subject headings
- Dermatitis, Atopic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbiatopDrug
Also called Probiotics
Dilute one sachet in 100ml of water and take it in every morning, once a day for 6 months.
PlaceboDrug
Also called Maltodextrin
1 sachet, once a day for 6 months. Dilute one sachet in 100ml of water and take it in every morning.
| Study group | Role | What they receive |
|---|---|---|
| Probiatop | Experimental | Probiotic comprising the mixture of strains: Lactobacillus rhamnosus, Lactobacillus acidophilus, Lactobacillus paracasei and Bifidobacterium lactis, at a dose of 1 gram sachet, once a day for 6 months Receives: Drug: Probiatop |
| Placebo | Placebo comparator | Placebo of Maltodextrin in sachet Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCORAD
Change from baseline in SCORAD every 3 months for 1 year
Measured: 1 year
Secondary outcomes (4)
Skin prick test (immediate awareness)
Measured: 1 year
Inflammation composite
ɣ - IFN, IL-1β, IL -4 , IL -6, IL-8 and tumor necrosis factor
Measured: 1 year
Immune tolerance composite
IL-10, TGF - β and IL -17
Measured: 1 year
Total serum IgE
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Casa Espirita Terra de Ismael
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Responsible party
- Principal investigator, Fabio Carmona, Casa Espirita Terra de Ismael
- Investigators
- Paula A Andrade, MD, Principal investigator, HCFMRP-USPPersio Roxo-Junior, MD, PhD, Study director, HCFMRP-USPVanessa Carregaro, PhD, Study chair, USP-RPJorgete Maria e Silva, MD, Msc, Study chair, HCFMRP-USPLuciana Roberti, Study chair, FMRP-USPLaís Sacramento, Msc, Study chair, USP-RP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02519556
- Sponsor's protocol ID
- ProbioticsAD2015
- Status last verified
- Jan 2021
- First submitted
- 4 Aug 2015
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Controlled Trial on Effectiveness Combined Probiotics in the Treatment of Atopic Dermatitis in Children
- ClinicalTrials.gov ID
- NCT02519556
- Acronym / sponsor ID
- ProbioticsAD2015
- Conditions
- Atopic Dermatitis
- Keywords
- Probiotics, Inflammation, Awareness, Immune tolerance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Casa Espirita Terra de IsmaelUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- Aug 2015 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 11 Aug 2015 (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.
Atopic dermatitis (AD) is an immune disorder, characterized by chronic skin inflammation or relapsing, whose prevalence is increasing worldwide. Its exact etiology remains unknown. The hypothesis that an appropriate early stimulation of the intestinal flora contributes to the establishment of the immune system balance has led to the use of probiotics in the prevention and treatment of AD in several clinical and experimental studies.
Therefore, the objectives of this study will evaluate the clinical efficacy of the mixture of probiotics (Lactobacillus and Bifidobacterium) in children with AD through the SCORAD (scoring atopic dermatitis) and to evaluate the effects of this medication in the following laboratory parameters: skin prick test, total serum immunoglobulin E (IgE), inflammation composite (interferon gamma [ɣ - IFN], interleukins [IL1-β, IL-4, IL-6, IL-8] and tumor necrosis factor alpha) and immune tolerance composite (IL-10, IL-17 and transforming growth factor beta [TGF - β]).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiatop | Experimental | Drug: ProbiatopProbiotic comprising the mixture of strains: Lactobacillus rhamnosus, Lactobacillus acidophilus, Lactobacillus paracasei and Bifidobacterium lactis, at a dose of 1 gram sachet, once a day for 6 months |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo of Maltodextrin in sachet |
Who may qualify
- Ages
- 6 months to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Clinical diagnosis of Atopic Dermatitis
- Children over 6 months.
- Teens lower than 19 years
- Diagnostic presence or clinical signs suggesting acute or chronic skin diseases, as well as pertinent to the study, which may affect the outcome of the research.
- Being in use of drugs that can affect systemically in the course of the disease, such as systemic corticosteroids and immunosuppressants, for at least 30 days.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ProbiatopAlso: ProbioticsDilute one sachet in 100ml of water and take it in every morning, once a day for 6 months. | Drug | Probiatop |
| PlaceboAlso: Maltodextrin1 sachet, once a day for 6 months. Dilute one sachet in 100ml of water and take it in every morning. | Drug | Placebo |
Primary outcome
SCORAD
Time frame: 1 year
Change from baseline in SCORAD every 3 months for 1 year
4 secondary outcomes
Skin prick test (immediate awareness)
Time frame: 1 year
Inflammation composite
Time frame: 1 year
Immune tolerance composite
Time frame: 1 year
Total serum IgE
Time frame: 1 year
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 28 Jan 2021.
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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.
Paula A Andrade, MD principal investigator
HCFMRP-USP
Persio Roxo-Junior, MD, PhD study director
HCFMRP-USP
Vanessa Carregaro, PhD study chair
USP-RP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Probiatop in people with Atopic Dermatitis, run by Casa Espirita Terra de Ismael at 1 site in Brazil.
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 10 inclusion and 0 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 28 Jan 2021. 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 Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
SCORAD (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2021.