Probiotics to infants with atopic dermatitis;

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2006
INTERVENTION: Product Name: Capsules containing either Lactobacillus acidophilus NCFM or Bifidobacterium lactis Bl‐07 Product Code: Probiotics Pharmaceutical Form: Powder for oral suspension Concentration type: up to Concentration number: 1x10 ^10 CFU ‐1 time a day Pharmaceutical form of the placebo: Powder for oral suspension Route of administration of the placebo: Oral use CONDITION: Infants participating in the clinical trial are suffering from atopic dermatitis PRIMARY OUTCOME: 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; ; Primary end point(s): 1. Clinical improvement of the eczema; ; 2. Reduced intestinal inflammtion/pemeability 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; ; 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
Epistemonikos ID: 26cd703374cf2fd181f7b893427b73156dc4aa05
First added on: Aug 21, 2024