Management of Eczema by Specific Probiotic Strains

NCT ID: NCT01230190

Last Updated: 2016-01-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2011-07-31

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).

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.

Conditions

Eczema; Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Probiotic mixture

participants daily ingest a selected probiotic mixture for a period of 3 months

Group Type: ACTIVE_COMPARATOR

Ecologic ® Panda II

Intervention Type: DIETARY_SUPPLEMENT

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

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

Placebo mixture

controls daily ingest a placebo mixture for a period of 3 months.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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.

Intervention Type: 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).

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

multispecies probiotic mixture; placebo mixture

Eligibility 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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 15 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Agentschap NL

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ministerie van Economische Zaken (Food & Nutrition Delta)

Principal Investigators

Arine M Vlieger, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Antonius Hospital

Locations

St. Antonius Ziekenhuis

Nieuwegein, Utrecht, Netherlands

Countries

Netherlands

Other Identifiers

BAMBOO

Identifier Type: -

Identifier Source: org_study_id