Atopic DermatitisNCT01007331
Probiotic Bacteria to Infants With Atopic Dermatitis
A study testing Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07 in people with Atopic Dermatitis, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The objective of the study is to examine whether 8 weeks intervention with probiotics influence the eczema in infants suffering from Atopic Dermatitis. Furthermore the influence of the immunologic status and the intestinal microflora, inflammation and permeability will be investigated. Read more about this study
- Who is it for?
- Ages 6 to 24 months
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 62 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2006to Jul 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 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Atopic dermatitis
Who cannot join
- Chronic diseases other than atopic dermatitis
- Chronic medication
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Institute of Human Nutrition
Rolighedsvej 30, Frederiksberg C, 1958
About this study
Official title: Probiotic Bacteria to Infants With Atopic Dermatitis; an Investigation of the Effect on Eczema, Immunologic Status and the Intestinal Microflora, Inflammation and Permeability
The objective of the study is to examine whether 8 weeks intervention with probiotics influence the eczema in infants suffering from Atopic Dermatitis. Furthermore the influence of the immunologic status and the intestinal microflora, inflammation and permeability will be investigated.
Read the detailed description
The aim of the study is to investigate whether two different probiotics influence the clinical and subjective symptoms in infants with Atopic Dermatitis (AD). The influence on the immunologic status and the intestinal microflora, inflammation and permeability will also be investigated.
Sixty two infants (6 to 24 months of age) suffering from AD will be randomised in 3 groups receiving either Lactobacillus acidophilus NCFM (1x10^10 Colony forming units), Bifidobacterium lactis Bi-07(1x10^10 Colony forming units) or placebo every day for 8 weeks.
At the beginning and at the end of the study the following analyses will be made:
- SCORing Atopic Dermatitis (SCORAD) index to describe the extent and severity of the eczema, and to describe the subjective symptoms.
- Blood samples will be drawn to examine:
- Immunoglobulin E (IgE), total and specific for egg and milk.
- Eosinophil Cation Protein (ECP)
- Interleukin-10 (Il-10), Interleukin-12 (Il-12) and Interferon-gamma (IFN-gamma)
- Fecal samples will be collected to examine:
- Calprotectin (intestinal inflammation)
- Bacterial Deoxyribonucleic acid (DNA) will be extracted in order to perform Polymerase chain reaction (PCR) analysis.
- Conditions
- Atopic Dermatitis
- Being tested
- Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07
- Keywords
- Infants, Atopic Dermatitis, SCORAD, IgE, Eosinophil Cation Protein, Calprotectin, Intestinal microflora
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07Behavioural
10^10 colony forming units pr day of probiotics
What is being measured
The primary outcome is the main question the study is designed to answer.
Scoring atopic dermatitis (SCORAD) index
Measured: 5 months
Secondary outcomes (9)
Immunoglobulin E (IgE) Total
Measured: 6 months
Immunoglobulin E (IgE) specific for Egg
Measured: 6 months
Immunoglobulin E (IgE) specific for Milk
Measured: 6 months
Interleukin-10 (Il-10)
Measured: 6 months
Interleukin-12 (Il-12)
Measured: 6 months
Interferon gamma (IFN-gamma)
Measured: 6 months
Calprotectin
Measured: one year
Polymerase Chain Reaction (PCR)
Measured: 8 months
Eosinophil Cation Protein (ECP)
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2009 (estimated)
- Study startNov 2006
- Primary completionJul 2008
- Study completionJul 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Investigators
- Kim F Michaelsen, Professor, Principal investigator, Department of Human Nutrition, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007331
- Sponsor's protocol ID
- KF-D200 Probørn
- Status last verified
- Nov 2009
- First submitted
- 3 Nov 2009
- Last updated
- 17 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotic Bacteria to Infants With Atopic Dermatitis; an Investigation of the Effect on Eczema, Immunologic Status and the Intestinal Microflora, Inflammation and Permeability
- ClinicalTrials.gov ID
- NCT01007331
- Acronym / sponsor ID
- KF-D200 Probørn
- Conditions
- Atopic Dermatitis
- Keywords
- Infants, Atopic Dermatitis, SCORAD, IgE, Eosinophil Cation Protein, Calprotectin, Intestinal microflora
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 4 Nov 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 objective of the study is to examine whether 8 weeks intervention with probiotics influence the eczema in infants suffering from Atopic Dermatitis. Furthermore the influence of the immunologic status and the intestinal microflora, inflammation and permeability will be investigated.
Detailed description
The aim of the study is to investigate whether two different probiotics influence the clinical and subjective symptoms in infants with Atopic Dermatitis (AD). The influence on the immunologic status and the intestinal microflora, inflammation and permeability will also be investigated.
Sixty two infants (6 to 24 months of age) suffering from AD will be randomised in 3 groups receiving either Lactobacillus acidophilus NCFM (1x10^10 Colony forming units), Bifidobacterium lactis Bi-07(1x10^10 Colony forming units) or placebo every day for 8 weeks.
At the beginning and at the end of the study the following analyses will be made:
- SCORing Atopic Dermatitis (SCORAD) index to describe the extent and severity of the eczema, and to describe the subjective symptoms.
- Blood samples will be drawn to examine:
- Immunoglobulin E (IgE), total and specific for egg and milk.
- Eosinophil Cation Protein (ECP)
- Interleukin-10 (Il-10), Interleukin-12 (Il-12) and Interferon-gamma (IFN-gamma)
- Fecal samples will be collected to examine:
- Calprotectin (intestinal inflammation)
- Bacterial Deoxyribonucleic acid (DNA) will be extracted in order to perform Polymerase chain reaction (PCR) analysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Atopic dermatitis
Key exclusion criteria (2 listed)
- Chronic diseases other than atopic dermatitis
- Chronic medication
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 |
|---|---|---|
| Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-0710^10 colony forming units pr day of probiotics | Behavioural | – |
Primary outcome
Scoring atopic dermatitis (SCORAD) index
Time frame: 5 months
9 secondary outcomes
Immunoglobulin E (IgE) Total
Time frame: 6 months
Immunoglobulin E (IgE) specific for Egg
Time frame: 6 months
Immunoglobulin E (IgE) specific for Milk
Time frame: 6 months
Interleukin-10 (Il-10)
Time frame: 6 months
Interleukin-12 (Il-12)
Time frame: 6 months
Interferon gamma (IFN-gamma)
Time frame: 6 months
Calprotectin
Time frame: one year
Polymerase Chain Reaction (PCR)
Time frame: 8 months
Eosinophil Cation Protein (ECP)
Time frame: 7 months
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 17 Feb 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.
Kim F Michaelsen, Professor principal investigator
Department of Human Nutrition, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07 in people with Atopic Dermatitis, run by University of Copenhagen at 1 site in Denmark.
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 1 inclusion and 2 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 17 Feb 2010. 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 Denmark. 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 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?
Scoring atopic dermatitis (SCORAD) index (time frame: 5 months). 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 17 Feb 2010.