Probiotics to infants with atopic dermatitis; an investigation of the effect on eczema, immune system and intestinal microflora, inflammation and permeability. DK-titel Probiotiske bakterier til børn med atopisk dermatitis; undersøgelse af effekten på eksem, immunstatus, intestinal mikroflora samt tarmens inflammation og permeabilitet

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-003140-56-DK

Enrollment

Unknown

Registered

2006-01-02

Start date

2006-02-10

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infants participating in the clinical trial are suffering from atopic dermatitis

Interventions

Product Name: Capsules containing either Lactobacillus acidophilus NCFM or Bifidobacterium lactis Bl-07 Product Code: Probiotics Pharmaceutical Form: Powder for oral suspension Concentration type: u

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Infants at the age of 5 months to 2 years with atopic dermatis, but otherwise healthy 2. Infants should fulfil the criteria of atopic dermatitis a. iching eczema within the past 6 weeks or chronic recurrent iching eczema b. characteristic symmetrical body location of the eczema depending on age c. clinical symptoms of atopic dermatitis on one or more of the following places: face/neck; trunk; flexor aspects of arms or legs; extensor aspects of arms or legs d. hereditary disposition Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Infants suffering from chronic diseases other than atopic dermatits 2. Infants recieving medication from other diseases than atopic dermatitis

Design outcomes

Primary

Measure	Time frame
Main Objective: • To investigate the influence of probiotics on : 1. the clinical symptoms of atopic dermatitis using the SCORAD system 2. the immune response in infants with atopic dermatitis 3. the intestinal inflammation and permeability 4. the general intestinal microflora ;Secondary Objective: 1. To decribe the probiotic influence on growth and body coposition in infants with atopic dermatitis 2. To investigate whether the cytokine and microflora of human milk influence the development of atopic dermatitis in the offspring ;Primary end point(s): 1. Clinical improvement of the eczema 2. Reduced intestinal inflammtion/pemeability	—

Measure

Time frame

Main Objective: • To investigate the influence of probiotics on : 1. the clinical symptoms of atopic dermatitis using the SCORAD system 2. the immune response in infants with atopic dermatitis 3. the intestinal inflammation and permeability 4. the general intestinal microflora ;Secondary Objective: 1. To decribe the probiotic influence on growth and body coposition in infants with atopic dermatitis 2. To investigate whether the cytokine and microflora of human milk influence the development of atopic dermatitis in the offspring ;Primary end point(s): 1. Clinical improvement of the eczema 2. Reduced intestinal inflammtion/pemeability

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Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026