Management of Eczema by Specific Probiotic Strains

Atopic Dermatitis Clinical Trial

— BAMBOO  

Official title:

Beyond Conventional Treatment of Atopic Eczema in Infants: Management By Specific prObiOtic Strains

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01230190
• Other study ID #: BAMBOO
• Status: Withdrawn
• Phase: Phase 3
• First received: October 28, 2010
• Last updated: January 11, 2016
• Start date: March 2011
• Est. completion date: July 2011

Study information

• Verified date: March 2011
• Source: Agentschap NL
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 15 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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.
• placebo
rice starch, maltodextrins, and mix of minerals. The placebo mixture is similar in aspect, consistency and taste as Ecologic ® Panda II (intervention).

Locations

Country	Name	City	State
Netherlands	St. Antonius Ziekenhuis	Nieuwegein	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Agentschap NL

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decrease in severity of atopic dermatitis	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.	6 months	Yes
Secondary	Effects on infant gut microbiota	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.	6 months	No
Secondary	Effects on the immature immune system	These effects will be measured by analyzing serum IgE and different (Th1/Th2) cytokines and chemokines	6 months	No