Atopic DermatitisPhase 3NCT00893230
A Study of a Probiotic in Atopic Dermatitis
A Phase 3 study testing probiotic L sakei KCTC 10755BP in people with Atopic Dermatitis, run by Chungbuk National University at 1 site in South Korea.
Trial summary
The aim of this study was to assess the clinical effect of Lactobacillus sakei supplementation in children with atopic dermatitis. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- probiotic L sakei KCTC 10755BP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2007to Nov 2008
- Phase
- Phase 3
- 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 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patients with atopic dermatitis present for at least 6 months before inclusion
- a total SCORAD score above 25
- a change in a total SCORAD score of not more than 10% within 2 weeks
Who cannot join
- patients who had been treated with cyclosporine, systemic steroid, topical calcineurin inhibitor, or Chinese herbal medicine during the preceding 3 months
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chungbuk National University Hospital
Cheongju-si, 361-711
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled Intervention Study of the Efficacy and Safety of "NFM proBio65" in the Atopic and Allergic Volunteers
The aim of this study was to assess the clinical effect of Lactobacillus sakei supplementation in children with atopic dermatitis.
Read the detailed description
Probiotics were also shown to reduce severity of AEDS when administered to infants with early onset AEDS. In contrast, only a few studies have evaluated the therapeutic effectiveness of probiotics on the groups of older children with established AEDS. In these studies, administration of Lactobacillus strains to unselected children aged 1 year and over was associated with improvement in the clinical severity of eczema. The purpose of this study was to evaluate the clinical efficacy in AEDS of a newly identified probiotic strain, Lactobacillus sakei KCTC 10755BP, which showed the most potent inhibitory activity against S aureus growth among Lactobacillus species in our preliminary experiment. We administered L sakei to an unselected group of children aged 2 to 10 years with moderate and severe AEDS and evaluated the clinical outcome at the end of the intervention. In addition, we also measured levels of serum chemokines as activity markers for AEDS to provide a more objective evidence for the beneficial role of this probiotic.
- Conditions
- Atopic Dermatitis
- Being tested
- probiotic L sakei KCTC 10755BP, microcrystalline cellulose (placebo)
- Keywords
- atopic dermatitis, chemokines, 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.
probiotic L sakei KCTC 10755BPDietary supplement
freeze-dried, 50,0000,0000 colony-forming units, twice daily, for 12 weeks
microcrystalline cellulose (placebo)Dietary supplement
freeze-dried, 50,0000,0000 colony-forming units, twice daily, for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus sakei KCTC 10755BP | Experimental | Not described Receives: Dietary Supplement: probiotic L sakei KCTC 10755BP |
| microcrystalline cellulose | Placebo comparator | Not described Receives: Dietary Supplement: microcrystalline cellulose (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCORAD score
Measured: 12 weeks
Secondary outcomes (1)
Chemokine levels
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 posted5 May 2009 (estimated)
- Study startJan 2007
- Primary completionNov 2008
- Study completionNov 2008
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chungbuk National University
- Sponsor type
- University, hospital or other
- Collaborators
- Yeungnam University Hospital, Korea Research Institute of Bioscience & Biotechnology, Gachon University Gil Medical Center
- Investigators
- Youn-Soo Hahn, MD, PhD, Principal investigator, Department of Pediatrics, College of Medicine and Medical Research Institute, Chungbuk National University, Cheongju, Korea,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893230
- Sponsor's protocol ID
- CS 7403-179
- Status last verified
- May 2009
- First submitted
- 4 May 2009
- Last updated
- 5 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled Intervention Study of the Efficacy and Safety of "NFM proBio65" in the Atopic and Allergic Volunteers
- ClinicalTrials.gov ID
- NCT00893230
- Acronym / sponsor ID
- CS 7403-179
- Conditions
- Atopic Dermatitis
- Keywords
- atopic dermatitis, chemokines, probiotics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Chungbuk National UniversityUniversity, hospital or other
- Collaborators
- Yeungnam University Hospital, Korea Research Institute of Bioscience & Biotechnology, Gachon University Gil Medical Center
- Study start
- Jan 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 5 May 2009 (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.
The aim of this study was to assess the clinical effect of Lactobacillus sakei supplementation in children with atopic dermatitis.
Detailed description
Probiotics were also shown to reduce severity of AEDS when administered to infants with early onset AEDS. In contrast, only a few studies have evaluated the therapeutic effectiveness of probiotics on the groups of older children with established AEDS. In these studies, administration of Lactobacillus strains to unselected children aged 1 year and over was associated with improvement in the clinical severity of eczema. The purpose of this study was to evaluate the clinical efficacy in AEDS of a newly identified probiotic strain, Lactobacillus sakei KCTC 10755BP, which showed the most potent inhibitory activity against S aureus growth among Lactobacillus species in our preliminary experiment. We administered L sakei to an unselected group of children aged 2 to 10 years with moderate and severe AEDS and evaluated the clinical outcome at the end of the intervention. In addition, we also measured levels of serum chemokines as activity markers for AEDS to provide a more objective evidence for the beneficial role of this probiotic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus sakei KCTC 10755BP | Experimental | Dietary Supplement: probiotic L sakei KCTC 10755BP |
| microcrystalline cellulose | Placebo comparator | Dietary Supplement: microcrystalline cellulose (placebo) |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- patients with atopic dermatitis present for at least 6 months before inclusion
- a total SCORAD score above 25
- a change in a total SCORAD score of not more than 10% within 2 weeks
Key exclusion criteria (1 listed)
- patients who had been treated with cyclosporine, systemic steroid, topical calcineurin inhibitor, or Chinese herbal medicine during the preceding 3 months
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 |
|---|---|---|
| probiotic L sakei KCTC 10755BPfreeze-dried, 50,0000,0000 colony-forming units, twice daily, for 12 weeks | Dietary supplement | Lactobacillus sakei KCTC 10755BP |
| microcrystalline cellulose (placebo)freeze-dried, 50,0000,0000 colony-forming units, twice daily, for 12 weeks | Dietary supplement | microcrystalline cellulose |
Primary outcome
SCORAD score
Time frame: 12 weeks
1 secondary outcome
Chemokine levels
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 5 May 2009.
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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.
Youn-Soo Hahn, MD, PhD principal investigator
Department of Pediatrics, College of Medicine and Medical Research Institute, Chungbuk National University, Cheongju, Korea,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing probiotic L sakei KCTC 10755BP in people with Atopic Dermatitis, run by Chungbuk National University at 1 site in South Korea.
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 3 inclusion and 1 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 5 May 2009. 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 South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 score (time frame: 12 weeks). 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 5 May 2009.