Atopic DermatitisNCT01045486
the Effectiveness of Probiotics on Atopic Dermatitis With Cow Milk Allergy
A study testing ATP mixed probiotics in people with Atopic Dermatitis, run by Soonchunhyang University Hospital.
Trial summary
There is not enough evidence to support the use of probiotics for prevention or treatment of AD in children in clinical practice. The purpose of this study is to determine whether probiotics is effective in the treatment of atopic dermatitis with cow milk allergy. Read more about this study
- Who is it for?
- Ages 6 months to 2 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- ATP mixed probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Sep 2010
- 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 months to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Under the 2 years old, 36 children
- Mild to moderate atopic dermatitis with cow milk allergy
- Volunteers who agreed by their parents.
- The severity of their disease was assessed by modified SCORAD index
Who cannot join
- Severe atopic dermatitis
- Patients on systemic steroids, immune-suppression or Korean herbal medicine during the previous 6 weeks
- Anaphylaxis, Angioedema, or severe allergic reaction to the cow milk
- Chronic diarrhea
About this study
Official title: A Double Blind, Randomized, Placebo-Controlled, Crossover Study to Compare the Effectiveness of Probiotics on Atopic Dermatitis With Cow Milk Allergy in Korean Infants
There is not enough evidence to support the use of probiotics for prevention or treatment of AD in children in clinical practice.
The purpose of this study is to determine whether probiotics is effective in the treatment of atopic dermatitis with cow milk allergy.
- Conditions
- Atopic Dermatitis
- Being tested
- ATP mixed probiotics, Placebo
- Keywords
- Atopic dermatitis, Food allergy, Probiotics
- Medical subject headings
- Dermatitis, Atopic, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATP mixed probioticsDrug
Also called DUOLAC
- Patients in Group A will receive ATP mixed probiotics for 6 weeks. And after 4 weeks wash-out period, they will receive placebo for 6 weeks
PlaceboDrug
Also called DUOLAC
- Patients in Group B will receive placebo for 6 weeks. And after 4 weeks wash-out period, they will receive ATP mixed probiotics for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A received active medication (ATP mixed probiotics) for 6 weeks followed by a crossover to 6 weeks of placebo after 4-weeks washout period. Receives: Drug: ATP mixed probiotics |
| Group B | Placebo comparator | Group B received placebo medication for 6 weeks followed by a crossover to 6 weeks of active medication (ATP mixed probiotics) after 4-weeks washout period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Check SCORAD index for severity of atopic dermatitis, symptom diary, blood cytokine and chemokine (IL-4,IL-6, IL-10, IL-13, total IgE, IFN-γ, TGF-β, TNF-α, and IgG4) after drug administration
Measured: 6 weeks after patient recruitment
Secondary outcomes (1)
Check SCORAD index for severity of atopic dermatitis, symptom diary, blood cytokine and chemokine (IL-4,IL-6, IL-10, IL-13, total IgE, IFN-γ, TGF-β, TNF-α, and IgG4) after drug administration
Measured: 6 weeks after wash-out period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionAug 2010 (estimated)
- Study completionSep 2010 (estimated)
Why it stopped: failed to enroll patients
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soonchunhyang University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Bok Yang Pyun, Study chair, Pediatric Allergy & Respiratory Center, Department of Pediatrics, Soonchunhyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045486
- Sponsor's protocol ID
- schprobiotics
- Status last verified
- Jul 2011
- First submitted
- 8 Jan 2010
- Last updated
- 21 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Placebo-Controlled, Crossover Study to Compare the Effectiveness of Probiotics on Atopic Dermatitis With Cow Milk Allergy in Korean Infants
- ClinicalTrials.gov ID
- NCT01045486
- Acronym / sponsor ID
- schprobiotics
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, Food allergy, Probiotics
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: failed to enroll patients
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 11 Jan 2010 (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.
There is not enough evidence to support the use of probiotics for prevention or treatment of AD in children in clinical practice.
The purpose of this study is to determine whether probiotics is effective in the treatment of atopic dermatitis with cow milk allergy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: ATP mixed probioticsGroup A received active medication (ATP mixed probiotics) for 6 weeks followed by a crossover to 6 weeks of placebo after 4-weeks washout period. |
| Group B | Placebo comparator | Drug: PlaceboGroup B received placebo medication for 6 weeks followed by a crossover to 6 weeks of active medication (ATP mixed probiotics) after 4-weeks washout period. |
Who may qualify
- Ages
- 6 months to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Under the 2 years old, 36 children
- Mild to moderate atopic dermatitis with cow milk allergy
- Volunteers who agreed by their parents.
- The severity of their disease was assessed by modified SCORAD index
Key exclusion criteria (4 listed)
- Severe atopic dermatitis
- Patients on systemic steroids, immune-suppression or Korean herbal medicine during the previous 6 weeks
- Anaphylaxis, Angioedema, or severe allergic reaction to the cow milk
- Chronic diarrhea
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 |
|---|---|---|
| ATP mixed probioticsAlso: DUOLAC- Patients in Group A will receive ATP mixed probiotics for 6 weeks. And after 4 weeks wash-out period, they will receive placebo for 6 weeks | Drug | Group A |
| PlaceboAlso: DUOLAC- Patients in Group B will receive placebo for 6 weeks. And after 4 weeks wash-out period, they will receive ATP mixed probiotics for 6 weeks | Drug | Group B |
Primary outcome
Check SCORAD index for severity of atopic dermatitis, symptom diary, blood cytokine and chemokine (IL-4,IL-6, IL-10, IL-13, total IgE, IFN-γ, TGF-β, TNF-α, and IgG4) after drug administration
Time frame: 6 weeks after patient recruitment
1 secondary outcome
Check SCORAD index for severity of atopic dermatitis, symptom diary, blood cytokine and chemokine (IL-4,IL-6, IL-10, IL-13, total IgE, IFN-γ, TGF-β, TNF-α, and IgG4) after drug administration
Time frame: 6 weeks after wash-out period
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2011.
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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.
Bok Yang Pyun study chair
Pediatric Allergy & Respiratory Center, Department of Pediatrics, Soonchunhyang University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing ATP mixed probiotics in people with Atopic Dermatitis, run by Soonchunhyang University Hospital.
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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 21 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Check SCORAD index for severity of atopic dermatitis, symptom diary, blood cytokine and chemokine (IL-4,IL-6, IL-10, IL-13, total IgE, IFN-γ, TGF-β, TNF-α, and IgG4) after drug administration (time frame: 6 weeks after patient recruitment). 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 21 Jul 2011.