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Management of Eczema by Specific Probiotic Strains (BAMBOO)

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ClinicalTrials.gov Identifier: NCT01230190
Recruitment Status : Withdrawn (Because of safety issues/support concerning the multispecies probiotic mixture)
First Posted : October 29, 2010
Last Update Posted : January 12, 2016
Sponsor:
Information provided by:
Agentschap NL

Brief Summary:
To investigate the therapeutic effect of a selected probiotic mixture on the severity of AD in infants aged 0-15 months. The probiotic mixture has been studied in laboratory setting and has proven IL-10 stimulating effects. Therefore it is thought to decrease AD severity in young children (beyond the conventional treatment).

Condition or disease Intervention/treatment Phase
Eczema Atopic Dermatitis Dietary Supplement: Ecologic ® Panda II Dietary Supplement: placebo Phase 3

Detailed Description:

Atopic dermatitis (AD) is a highly prevalent chronic, itching, inflammatory skin disease that often presents in infancy. The disease can be the first manifestation of the so-called atopic march, the natural progression of allergic disorders, with subsequent development of asthma and allergic rhinitis. Approximately 40% of the children with AD will develop asthma later in childhood.

Currently, topical corticosteroids are the mainstay treatment of atopic dermatitis; however, relapses are common and parents often fear possible side-effects, leading to non-compliance. There is increasing evidence that the intestinal microbiota plays an important role in the development of allergic diseases. Modulation of the intestinal microbiota with probiotics, living micro-organisms with immunomodulatory effects, could possibly offer a new way of treatment of allergic disease.

Clinical trials investigating the preventive as well as therapeutic effect of probiotics on atopic dermatitis show inconsistent results. Systematic (Cochrane) reviews of all clinical trials (about treatment of AD by use of probiotics) concluded that the probiotic strains studied to date are not an effective treatment for AD; however, there is great heterogeneity between studies since many different probiotic strains are used. Because of the known strain specific capacity in immunomodulatory effects, some strains might have a greater effect than others.

Better results can possibly be achieved by using a selected, (in laboratory setting) proven modulatory multispecies probiotic mixture, containing 6 different strains.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Beyond Conventional Treatment of Atopic Eczema in Infants: Management By Specific prObiOtic Strains
Study Start Date : March 2011
Estimated Primary Completion Date : July 2011
Estimated Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Active Comparator: Probiotic mixture
participants daily ingest a selected probiotic mixture for a period of 3 months
Dietary Supplement: Ecologic ® Panda II

Probiotic strains: 3 Bifidobacteria, 3 Lactococci, 1*10^9 Colony Forming Units/g.

Composition: rice starch, maltodextrins, bacterial strains and mix of minerals.

Other Name: multispecies probiotic mixture

Placebo Comparator: Placebo mixture
controls daily ingest a placebo mixture for a period of 3 months.
Dietary Supplement: placebo
rice starch, maltodextrins, and mix of minerals. The placebo mixture is similar in aspect, consistency and taste as Ecologic ® Panda II (intervention).
Other Name: placebo mixture




Primary Outcome Measures :
  1. decrease in severity of atopic dermatitis [ Time Frame: 6 months ]

    The primary outcome will be measured by change in the severity of AD by using the SCORAD score.

    Other outcomes: subjective (parental) change in eczema severity, change in amount of and type of topical steroid use, quality of life during and after intervention (measured by ITQOL questionnaire), amount of respiratory tract infections, use of antibiotics, use of primary care medicine (general practitioner).

    All used probiotic strains contain the QPS status. (serious) adverse events will be recorded systematically.



Secondary Outcome Measures :
  1. Effects on infant gut microbiota [ Time Frame: 6 months ]
    Analyses will be done by molecular microbiological techniques on feces samples (that will be collected at baseline, and after 1,3 and 6 months after enrollment.

  2. Effects on the immature immune system [ Time Frame: 6 months ]
    These effects will be measured by analyzing serum IgE and different (Th1/Th2) cytokines and chemokines



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Ages Eligible for Study:   up to 15 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • children 0-15 months with mild to moderate eczema (SCORAD score 15-50 or equally EASI score) for at least two weeks

Exclusion Criteria:

  • use of topical steroids class II or higher (which means treatment for severe eczema),
  • use of oral steroids or treatment with antibiotics prior to inclusion.
  • severe comorbidity
  • lack of knowledge of the Dutch language

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01230190


Locations
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Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Utrecht, Netherlands, 3430 EM
Sponsors and Collaborators
Agentschap NL
Investigators
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Principal Investigator: Arine M Vlieger, MD, PhD St. Antonius Ziekenhuis Nieuwegein, The Netherlands

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Responsible Party: Agentschap NL, Ministerie van Economische Zaken, Ministerie van Economische Zaken (Food & Nutrition Delta)
ClinicalTrials.gov Identifier: NCT01230190     History of Changes
Other Study ID Numbers: BAMBOO
First Posted: October 29, 2010    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: March 2011

Keywords provided by Agentschap NL:
infants
adaptive immunology
atopic dermatitis
probiotics

Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases