Atopic DermatitisNCT00378300
The Effects of Probiotics in Atopic Dermatitis
A study testing Oral Probiotics in people with Atopic Dermatitis, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The purpose of this study is to study the clinical effects of taking probiotics in patients who have moderate to severe atopic dermatitis. There has been several studies showing improvement in the severity of atopic dermatitis after taking probiotics. The mechanism of this improvement is currently unknown. Read more about this study
- Who is it for?
- Ages 6 months to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Oral Probiotics
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jun 2008
- 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 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age between 6 months to 3 years
- Physician diagnosis of moderate to severe atopic dermatitis as defined by the Hanifin and Rajka criteria
- Ability to take enterally commercially available probiotics by powder form added to food or drink
- Ability to undergo venipuncture or dermal puncture (if less than 1 year old)
Who cannot join
- Prior exposure to probiotics
- Current antibiotic administration
- Known history of chronic medical condition such as congenital heart disease, liver or kidney disease, or immune deficiency
- Absence of T regulatory cell induction by probiotic bacteria on initial laboratory assessment
- Any other condition in which the Investigators involved in the study determine potential subject is unsuitable for the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Probiotics Ameliorate Atopic Dermatitis by Induction of T Regulatory Cells
The purpose of this study is to study the clinical effects of taking probiotics in patients who have moderate to severe atopic dermatitis. There has been several studies showing improvement in the severity of atopic dermatitis after taking probiotics. The mechanism of this improvement is currently unknown. We propose that probiotics improve atopic dermatitis by stimulating, or increasing, the activity of a special type of cell called the T Regulatory cell--which can suppress the activity of allergic disease.
Read the detailed description
The central hypothesis of this study is that a subset of commercially available probiotic formulations will ameliorate moderate to severe atopic dermatitis in children by inducing the development of T Regulatory (Treg) cells. We specifically hypothesize that the probiotic mixture that induces Treg activity in vitro, will also improve the severity of atopic dermatitis in a specific patient by inducing Treg activity in vivo.
- We will determine whether probiotic mixtures are better able to ameliorate the severity of atopic dermatitis when compared to patients treated with placebo. We will conduct a 4-week randomized, double-blind, placebo controlled clinical trial designed to evaluate the efficacy of probiotics in reducing the clinical severity of atopic dermatitis as assessed by our primary outcome measure, the SCORing Atopic Dermatitis (SCORAD) index. We specifically hypothesize that probiotics will clinically improve the disease.
- We will assess whether probiotic mixtures induce the development of T regulatory cells in patients with atopic dermatitis.
- We will measure the relative levels of Tregs in peripheral blood before and after probiotic or placebo administration in order to assess whether the probiotic mixtures alter Treg development in vivo, and whether these changes correlate with improvement in clinical scores. Primary outcomes will be measurements of gene expression and absolute increases in cell population. We specifically hypothesize that probiotics will increase Treg activity.
- We will also determine if all patients' Tregs have in vitro responses to probiotics. This data will be used to correlate whether clinical responders in the study also have strong in vitro responses.
- Conditions
- Atopic Dermatitis
- Being tested
- Oral Probiotics
- Keywords
- Atopic Dermatitis, Probiotics, T Regulatory Cells
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral ProbioticsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
SCORAD Score change taken at baseline and after 1 month of either probiotic or placebo
T Regulatory cell activity change taken at baseline and after 1 month of either probiotic or placebo
Secondary outcomes (3)
Dermatitis Family Impact Questionnaire change taken at baseline and after 1 month of either probiotic or placebo
T Regulatory cell activity when exposed to probiotics in vitro
Change in Serum IgE or IgG levels taken at baseline and after 1 month of either probiotic or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2006 (estimated)
- Study startJul 2007
- Primary completionJun 2008
- Study completionJun 2008 (estimated)
Why it stopped: Inadequate funding to support this fellow-in-training initiated study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund
- Investigators
- Michael H Land, MD, Principal investigator, University of California, Los AngelesMartin G Martin, MD, MPP, Principal investigator, University of California, Los AngelesRobert L Roberts, MD, PhD, Principal investigator, University of California, Los AngelesTatiana Hernandez, Study director, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00378300
- Sponsor's protocol ID
- 06-08-007-01
- Status last verified
- Mar 2016
- First submitted
- 18 Sep 2006
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kalliomaki M, Salminen S, Arvilommi H, Kero P, Koskinen P, Isolauri E. Probiotics in primary prevention of atopic disease: a randomised placebo-controlled trial. Lancet. 2001 Apr 7;357(9262):1076-9. doi: 10.1016/S0140-6736(00)04259-8.
PubMed 11297958Isolauri 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 11069570Pessi T, Sutas Y, Hurme M, Isolauri E. Interleukin-10 generation in atopic children following oral Lactobacillus rhamnosus GG. Clin Exp Allergy. 2000 Dec;30(12):1804-8. doi: 10.1046/j.1365-2222.2000.00948.x.
PubMed 11122221Kalliomaki M, Salminen S, Poussa T, Arvilommi H, Isolauri E. Probiotics and prevention of atopic disease: 4-year follow-up of a randomised placebo-controlled trial. Lancet. 2003 May 31;361(9372):1869-71. doi: 10.1016/S0140-6736(03)13490-3.
PubMed 12788576Rosenfeldt V, Benfeldt E, Nielsen SD, Michaelsen KF, Jeppesen DL, Valerius NH, Paerregaard A. Effect of probiotic Lactobacillus strains in children with atopic dermatitis. J Allergy Clin Immunol. 2003 Feb;111(2):389-95. doi: 10.1067/mai.2003.389.
PubMed 12589361Weston 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 15863468Viljanen M, Savilahti E, Haahtela T, Juntunen-Backman K, Korpela R, Poussa T, Tuure T, Kuitunen M. Probiotics in the treatment of atopic eczema/dermatitis syndrome in infants: a double-blind placebo-controlled trial. Allergy. 2005 Apr;60(4):494-500. doi: 10.1111/j.1398-9995.2004.00514.x.
PubMed 15727582Smits HH, Engering A, van der Kleij D, de Jong EC, Schipper K, van Capel TM, Zaat BA, Yazdanbakhsh M, Wierenga EA, van Kooyk Y, Kapsenberg ML. Selective probiotic bacteria induce IL-10-producing regulatory T cells in vitro by modulating dendritic cell function through dendritic cell-specific intercellular adhesion molecule 3-grabbing nonintegrin. J Allergy Clin Immunol. 2005 Jun;115(6):1260-7. doi: 10.1016/j.jaci.2005.03.036.
PubMed 15940144
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics Ameliorate Atopic Dermatitis by Induction of T Regulatory Cells
- ClinicalTrials.gov ID
- NCT00378300
- Acronym / sponsor ID
- 06-08-007-01
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis, Probiotics, T Regulatory Cells
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Inadequate funding to support this fellow-in-training initiated study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Thrasher Research Fund
- Study start
- Jul 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (estimated)
- First posted
- 19 Sep 2006 (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 purpose of this study is to study the clinical effects of taking probiotics in patients who have moderate to severe atopic dermatitis. There has been several studies showing improvement in the severity of atopic dermatitis after taking probiotics. The mechanism of this improvement is currently unknown. We propose that probiotics improve atopic dermatitis by stimulating, or increasing, the activity of a special type of cell called the T Regulatory cell--which can suppress the activity of allergic disease.
Detailed description
The central hypothesis of this study is that a subset of commercially available probiotic formulations will ameliorate moderate to severe atopic dermatitis in children by inducing the development of T Regulatory (Treg) cells. We specifically hypothesize that the probiotic mixture that induces Treg activity in vitro, will also improve the severity of atopic dermatitis in a specific patient by inducing Treg activity in vivo.
- We will determine whether probiotic mixtures are better able to ameliorate the severity of atopic dermatitis when compared to patients treated with placebo. We will conduct a 4-week randomized, double-blind, placebo controlled clinical trial designed to evaluate the efficacy of probiotics in reducing the clinical severity of atopic dermatitis as assessed by our primary outcome measure, the SCORing Atopic Dermatitis (SCORAD) index. We specifically hypothesize that probiotics will clinically improve the disease.
- We will assess whether probiotic mixtures induce the development of T regulatory cells in patients with atopic dermatitis.
- We will measure the relative levels of Tregs in peripheral blood before and after probiotic or placebo administration in order to assess whether the probiotic mixtures alter Treg development in vivo, and whether these changes correlate with improvement in clinical scores. Primary outcomes will be measurements of gene expression and absolute increases in cell population. We specifically hypothesize that probiotics will increase Treg activity.
- We will also determine if all patients' Tregs have in vitro responses to probiotics. This data will be used to correlate whether clinical responders in the study also have strong in vitro responses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 6 months to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age between 6 months to 3 years
- Physician diagnosis of moderate to severe atopic dermatitis as defined by the Hanifin and Rajka criteria
- Ability to take enterally commercially available probiotics by powder form added to food or drink
- Ability to undergo venipuncture or dermal puncture (if less than 1 year old)
Key exclusion criteria (5 listed)
- Prior exposure to probiotics
- Current antibiotic administration
- Known history of chronic medical condition such as congenital heart disease, liver or kidney disease, or immune deficiency
- Absence of T regulatory cell induction by probiotic bacteria on initial laboratory assessment
- Any other condition in which the Investigators involved in the study determine potential subject is unsuitable for the study
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 |
|---|---|---|
| Oral Probiotics | Drug | – |
Primary outcome
SCORAD Score change taken at baseline and after 1 month of either probiotic or placebo
T Regulatory cell activity change taken at baseline and after 1 month of either probiotic or placebo
3 secondary outcomes
Dermatitis Family Impact Questionnaire change taken at baseline and after 1 month of either probiotic or placebo
T Regulatory cell activity when exposed to probiotics in vitro
Change in Serum IgE or IgG levels taken at baseline and after 1 month of either probiotic or placebo
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 16 Mar 2016.
- Background: PubMed 11297958Kalliomaki M, Salminen S, Arvilommi H, Kero P, Koskinen P, Isolauri E. Probiotics in primary prevention of atopic disease: a randomised placebo-controlled trial. Lancet. 2001 Apr 7;357(9262):1076-9. doi: 10.1016/S0140-6736(00)04259-8.
- 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 11122221Pessi T, Sutas Y, Hurme M, Isolauri E. Interleukin-10 generation in atopic children following oral Lactobacillus rhamnosus GG. Clin Exp Allergy. 2000 Dec;30(12):1804-8. doi: 10.1046/j.1365-2222.2000.00948.x.
- Background: PubMed 12788576Kalliomaki M, Salminen S, Poussa T, Arvilommi H, Isolauri E. Probiotics and prevention of atopic disease: 4-year follow-up of a randomised placebo-controlled trial. Lancet. 2003 May 31;361(9372):1869-71. doi: 10.1016/S0140-6736(03)13490-3.
- Background: PubMed 12589361Rosenfeldt V, Benfeldt E, Nielsen SD, Michaelsen KF, Jeppesen DL, Valerius NH, Paerregaard A. Effect of probiotic Lactobacillus strains in children with atopic dermatitis. J Allergy Clin Immunol. 2003 Feb;111(2):389-95. doi: 10.1067/mai.2003.389.
- 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 15727582Viljanen M, Savilahti E, Haahtela T, Juntunen-Backman K, Korpela R, Poussa T, Tuure T, Kuitunen M. Probiotics in the treatment of atopic eczema/dermatitis syndrome in infants: a double-blind placebo-controlled trial. Allergy. 2005 Apr;60(4):494-500. doi: 10.1111/j.1398-9995.2004.00514.x.
- Background: PubMed 15940144Smits HH, Engering A, van der Kleij D, de Jong EC, Schipper K, van Capel TM, Zaat BA, Yazdanbakhsh M, Wierenga EA, van Kooyk Y, Kapsenberg ML. Selective probiotic bacteria induce IL-10-producing regulatory T cells in vitro by modulating dendritic cell function through dendritic cell-specific intercellular adhesion molecule 3-grabbing nonintegrin. J Allergy Clin Immunol. 2005 Jun;115(6):1260-7. doi: 10.1016/j.jaci.2005.03.036.
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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.
Michael H Land, MD principal investigator
University of California, Los Angeles
Martin G Martin, MD, MPP principal investigator
University of California, Los Angeles
Robert L Roberts, MD, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Probiotics in people with Atopic Dermatitis, run by University of California, Los Angeles at 1 site in United States.
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 5 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 16 Mar 2016. 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 United States. 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. 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?
SCORAD Score change taken at baseline and after 1 month of either probiotic or placebo. The study lists 2 primary outcomes in all. 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 NCT00378300, which also lists 8 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 16 Mar 2016.