Management of Eczema by Specific Probiotic Strains (BAMBOO)

January 11, 2016 updated by: Agentschap NL

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

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / 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.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Utrecht
      • Nieuwegein, Utrecht, Netherlands, 3430 EM
        • St. Antonius Ziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • placebo mixture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Agentschap NL

Investigators

  • Principal Investigator: Arine M Vlieger, MD, PhD, St. Antonius Ziekenhuis Nieuwegein, The Netherlands

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

July 1, 2011

Study Completion (Anticipated)

July 1, 2011

Study Registration Dates

First Submitted

October 28, 2010

First Submitted That Met QC Criteria

October 28, 2010

First Posted (Estimate)

October 29, 2010

Study Record Updates

Last Update Posted (Estimate)

January 12, 2016

Last Update Submitted That Met QC Criteria

January 11, 2016

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BAMBOO (Allergan)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Eczema

Clinical Trials on Ecologic ® Panda II

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe