Atopic DermatitisNCT00224432
Double-Blind, Parallel, Randomised Study to Investigate the Effect of Oral Probiotics in Infants With Atopic Dermatitis
A study testing probiotics: Lactobacillus GG, lactobacillus Rhamnosus in people with Atopic Dermatitis and Atopic Eczema, run by Groningen Research Institute for Asthma and COPD at 1 site in Netherlands.
Trial summary
To study the effect of supplementation of a hydrolyzed formula with probiotic bacteria on clinical and immunological parameters in infants with AD with and without CMA and to compare effectiveness of different strains of probiotics. Read more about this study
- Who is it for?
- Ages 0 years to 5 months
- Conditions the study is for
- Atopic Dermatitis, Atopic Eczema, Infantile Eczema
- What is being tested?
- probiotics: Lactobacillus GG, lactobacillus Rhamnosus
- How many people
- 45 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2001to Sep 2002
- 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 0 years to 5 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Term infants fulfilling the Hanifin (1989) criteria for atopic dermatitis
- Suggestive of CMA (one additional symptom)
- Scorad index (total) >20 at study entry
- Below 5 months of age
- Formula, not breast fed
- Written informed consent from the parents
Who cannot join
- • Previous or current use of anti-histamines, oral corticosteroids, probiotics
- Use of systemic antibiotic or anti-mycotic drugs in the previous 4 weeks
- Congenital intestinal abnormality (eg. Hirschsprung's disease, intestinal atresia)
- Other GI disease with intestinal inflammation and/or increased intestinal permeability
- Skin disorder, not atopic dermatitis
- Participation in another clinical study
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Beatrix Children's Hospital, University Medical Center Groningen
Groningen, 9700 RB
About this study
Official title: Double-Blind, Parallel, Randomised Study to Investigate the Clinical and Immunological Effects of Oral Administration of Probiotic Bacteria in Infants With Atopic Dermatitis With and Without Cow's Milk Allergy.
To study the effect of supplementation of a hydrolyzed formula with probiotic bacteria on clinical and immunological parameters in infants with AD with and without CMA and to compare effectiveness of different strains of probiotics.
Read the detailed description
- To determine the effect of supplementation of a hydrolyzed formula with probiotic bacteria on clinical and immunological parameters in infants with AD with and without CMA
- To determine the effect of supplementation of a hydrolyzed formula with probiotic bacteria on clinical and immunological reactivity to cow' milk challenge in infants with AD with CMA
- To compare the effectiveness of different strains of probiotic bacteria in improving clinical and immunological outcome in these infants
- Conditions
- Atopic Dermatitis, Atopic Eczema, Infantile Eczema
- Being tested
- probiotics: Lactobacillus GG, lactobacillus Rhamnosus
- Keywords
- Atopic Dermatitis, SCORAD, probiotics, cytokines, Infant
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probiotics: Lactobacillus GG, lactobacillus RhamnosusDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant decrease of SCORAD score in treated infants compared to placebo
Secondary outcomes (3)
IL-4, IL-5 and IFN-gamma production of stimulated peripheral blood mononuclear cells
change in fecal TNF-α and α-1-antitrypsin, urinary EDN
effect on faecal bacteria after probiotics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startMar 2001
- Study completionSep 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- Groningen Research Institute for Asthma and COPD
- Sponsor type
- University, hospital or other
- Collaborators
- Numico Research Wageningen, the Netherlands
- Investigators
- Eric J Duiverman, MD, PhD, Principal investigator, Dept of Pediatric Pulmonology, University Medical Center Groningen, The NetherlandsMarianne L Brouwer, MD, Principal investigator, Dept of Pediatric Pulmonology, University Medical Center Groningen, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00224432
- Sponsor's protocol ID
- METc/99/07/116
- Status last verified
- Sep 2006
- First submitted
- 13 Sep 2005
- Last updated
- 27 Sep 2006
- Results posted
- No
Publications
Brouwer ML, Wolt-Plompen SA, Dubois AE, van der Heide S, Jansen DF, Hoijer MA, Kauffman HF, Duiverman EJ. No effects of probiotics on atopic dermatitis in infancy: a randomized placebo-controlled trial. Clin Exp Allergy. 2006 Jul;36(7):899-906. doi: 10.1111/j.1365-2222.2006.02513.x.
PubMed 16839405
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Parallel, Randomised Study to Investigate the Clinical and Immunological Effects of Oral Administration of Probiotic Bacteria in Infants With Atopic Dermatitis With and Without Cow's Milk Allergy.
- ClinicalTrials.gov ID
- NCT00224432
- Acronym / sponsor ID
- METc/99/07/116
- Conditions
- Atopic Dermatitis, Atopic Eczema, Infantile Eczema
- Keywords
- Atopic Dermatitis, SCORAD, probiotics, cytokines, Infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants
- Lead sponsor
- Groningen Research Institute for Asthma and COPDUniversity, hospital or other
- Collaborators
- Numico Research Wageningen, the Netherlands
- Study start
- Mar 2001
- Study completion
- Sep 2002
- First posted
- 23 Sep 2005 (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.
To study the effect of supplementation of a hydrolyzed formula with probiotic bacteria on clinical and immunological parameters in infants with AD with and without CMA and to compare effectiveness of different strains of probiotics.
Detailed description
- To determine the effect of supplementation of a hydrolyzed formula with probiotic bacteria on clinical and immunological parameters in infants with AD with and without CMA
- To determine the effect of supplementation of a hydrolyzed formula with probiotic bacteria on clinical and immunological reactivity to cow' milk challenge in infants with AD with CMA
- To compare the effectiveness of different strains of probiotic bacteria in improving clinical and immunological outcome in these infants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 0 years to 5 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Term infants fulfilling the Hanifin (1989) criteria for atopic dermatitis
Key exclusion criteria (6 listed)
- • Previous or current use of anti-histamines, oral corticosteroids, probiotics
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 |
|---|---|---|
| probiotics: Lactobacillus GG, lactobacillus Rhamnosus | Drug | – |
Primary outcome
Significant decrease of SCORAD score in treated infants compared to placebo
3 secondary outcomes
IL-4, IL-5 and IFN-gamma production of stimulated peripheral blood mononuclear cells
change in fecal TNF-α and α-1-antitrypsin, urinary EDN
effect on faecal bacteria after probiotics
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 27 Sep 2006.
- Results publication: PubMed 16839405Brouwer ML, Wolt-Plompen SA, Dubois AE, van der Heide S, Jansen DF, Hoijer MA, Kauffman HF, Duiverman EJ. No effects of probiotics on atopic dermatitis in infancy: a randomized placebo-controlled trial. Clin Exp Allergy. 2006 Jul;36(7):899-906. doi: 10.1111/j.1365-2222.2006.02513.x.
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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.
Eric J Duiverman, MD, PhD principal investigator
Dept of Pediatric Pulmonology, University Medical Center Groningen, The Netherlands
Marianne L Brouwer, MD principal investigator
Dept of Pediatric Pulmonology, University Medical Center Groningen, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probiotics: Lactobacillus GG, lactobacillus Rhamnosus in people with Atopic Dermatitis and Atopic Eczema, run by Groningen Research Institute for Asthma and COPD at 1 site in Netherlands.
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 6 inclusion and 6 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 27 Sep 2006. 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 Netherlands. 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?
Significant decrease of SCORAD score in treated infants compared to placebo. 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 NCT00224432, which also lists 1 linked publication.
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 27 Sep 2006.