Management of Eczema by Specific Probiotic Strains

NCT01230190 | Withdrawn Phase 3 DMC

• 1 other identifier: BAMBOO
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Eczema; Atopic Dermatitis

Keywords

infants; adaptive immunology; atopic dermatitis; probiotics

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Effects on infant gut microbiota

  6 months

• Effects on the immature immune system

  6 months

Study Arms (2)

Probiotic mixture

ACTIVE COMPARATOR

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

Dietary Supplement: Ecologic ® Panda II

Placebo mixture

PLACEBO COMPARATOR

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

Dietary Supplement: placebo

Interventions

Ecologic ® Panda II 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.

Also known as: multispecies probiotic mixture

Probiotic mixture

placebo DIETARY_SUPPLEMENT

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

Also known as: placebo mixture

Placebo mixture

Eligibility Criteria

• Age: 1 Day - 15 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• use of topical steroids class II or higher (which means treatment for severe eczema),
• severe comorbidity
• lack of knowledge of the Dutch language

Sponsors & Collaborators

• Agentschap NL: lead

Study Sites (1)

St. Antonius Ziekenhuis

Nieuwegein, Utrecht, 3430 EM, Netherlands

Location

MeSH Terms

Conditions

Eczema; Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Arine M Vlieger, MD, PhD

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: October 28, 2010
• First Posted: October 29, 2010
• Study Start: March 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: January 12, 2016

Record last verified: 2011-03

Locations

NL (1)