Atopic Dermatitis, ProbioticsPhase 3NCT01224132
Effect of Probiotics in the Atopic Dermatitis
A Phase 3 study testing probiotic ® pur in people with Atopic Dermatitis, Probiotics, run by Yuzuncu Yil University.
Trial summary
This study was designed to evaluate the efficacy of probiotics in the treatment of atopic dermatitis. Probiotics in AD patients were effective in reducing SCORAD index levels, but not effective in skin prick test positivity, serum IL-2-4-5-6-10, TNF-α, IFN-γ, ECP, and serum total and specific IgE levels. Read more about this study
- Who is it for?
- Ages 8 to 8 weeksHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, Probiotics
- What is being tested?
- probiotic ® pur
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to Apr 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 8 to 8 weeks
- All sexes
- Healthy volunteers accepted
- Child
Inclusion Criteria:SCORAD (SCORing Atopic Dermatitis) index is based on medium-heavy (Carr 2006). Age range is 1-13 with no patient showing evidence of any other disease except the existent disease -
Exclusion Criteria:No drug was used for 14 (fourteen) days prior to study, including antihistamines and steroids. Also, no occurrence of malabsorption, such as gastrointestinal disease, was detected.
-
About this study
Official title: Effect of Probiotics in the Treatment of Children With Atopic Dermatitis
This study was designed to evaluate the efficacy of probiotics in the treatment of atopic dermatitis. Probiotics in AD patients were effective in reducing SCORAD index levels, but not effective in skin prick test positivity, serum IL-2-4-5-6-10, TNF-α, IFN-γ, ECP, and serum total and specific IgE levels.
Read the detailed description
Frequently encountered in clinical practice, in the last 30 years, the prevalence of AD has rapidly increased as a result of industrialization. Thus, a new wave of quests for the treatment and prevention of AD has pushed forward. For the randomized, double-blinded, and placebo-controlled study this study was designed to evaluate the efficacy of probiotics in the treatment of AD. SCORAD positivity index of decline rates decline rates of the probiotic group of patients after treatment and skin prick tests were higher than that of the control group. While serum levels of IL-2-4-5-6-10, TNF-α, IFN-γ, ECP decreased in the probiotic group, only levels of IL-2-4-5, TNF-α decreased in the control group. The IgE decrease rate, the skin prick test, the serum total and specific of the probiotic group showed no difference from those of the control group. Probiotics in AD patients were effective in reducing SCORAD index levels, but not effective in skin prick test positivity, serum IL-2-4-5-6-10, TNF-α, IFN-γ, ECP, and serum total and specific IgE levels.
- Conditions
- Atopic Dermatitis, Probiotics
- Being tested
- probiotic ® pur
- Keywords
- Atopic dermatitis, probiotic, SCORAD index, prick tests, cytokines
- 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 ® purDrug
daily, four types of probiotic bacteria ( Bifidobacterium bifidity, Lactobacillus acidophilus, Lactobacillus casei and Lactobacillus salivarium) 2 bags (two billion bacteria) (probiotic ® pur) for a total of 8 (eight) weeks
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | No intervention | Not described Receives: Drug: probiotic ® pur |
| skim milk powder, dextrose | No intervention | Not described Receives: Drug: probiotic ® pur |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2010 (estimated)
- Study startOct 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis, ProbioticsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224132
- Sponsor's protocol ID
- JID-2010-0484
- Status last verified
- May 2008
- First submitted
- 18 Oct 2010
- Last updated
- 19 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotics in the Treatment of Children With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT01224132
- Acronym / sponsor ID
- JID-2010-0484
- Conditions
- Atopic Dermatitis, Probiotics
- Keywords
- Atopic dermatitis, probiotic, SCORAD index, prick tests, cytokines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 19 Oct 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.
This study was designed to evaluate the efficacy of probiotics in the treatment of atopic dermatitis. Probiotics in AD patients were effective in reducing SCORAD index levels, but not effective in skin prick test positivity, serum IL-2-4-5-6-10, TNF-α, IFN-γ, ECP, and serum total and specific IgE levels.
Detailed description
Frequently encountered in clinical practice, in the last 30 years, the prevalence of AD has rapidly increased as a result of industrialization. Thus, a new wave of quests for the treatment and prevention of AD has pushed forward. For the randomized, double-blinded, and placebo-controlled study this study was designed to evaluate the efficacy of probiotics in the treatment of AD. SCORAD positivity index of decline rates decline rates of the probiotic group of patients after treatment and skin prick tests were higher than that of the control group. While serum levels of IL-2-4-5-6-10, TNF-α, IFN-γ, ECP decreased in the probiotic group, only levels of IL-2-4-5, TNF-α decreased in the control group. The IgE decrease rate, the skin prick test, the serum total and specific of the probiotic group showed no difference from those of the control group. Probiotics in AD patients were effective in reducing SCORAD index levels, but not effective in skin prick test positivity, serum IL-2-4-5-6-10, TNF-α, IFN-γ, ECP, and serum total and specific IgE levels.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics | No intervention | Drug: probiotic ® pur |
| skim milk powder, dextrose | No intervention | Drug: probiotic ® pur |
Who may qualify
- Ages
- 8 to 8 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
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 ® purdaily, four types of probiotic bacteria ( Bifidobacterium bifidity, Lactobacillus acidophilus, Lactobacillus casei and Lactobacillus salivarium) 2 bags (two billion bacteria) (probiotic ® pur) for a total of 8 (eight) weeks | Drug | Probiotics, skim milk powder, dextrose |
Primary outcome
Not reported in the source record.
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 19 Oct 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing probiotic ® pur in people with Atopic Dermatitis, Probiotics, run by Yuzuncu Yil University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 19 Oct 2010. 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. 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.
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 19 Oct 2010.