title: Treatment and secondary prevention effects of the probiotics Lactobacillus paracasei or Bifidobacterium lactis on early infant eczema: randomized controlled trial with follow-up until age 3 years.
abstract: BACKGROUND
  Allergic disease has been associated with altered intestinal microbiota. Therefore, probiotics have been suggested as a potential treatment for eczema.
  
  
  OBJECTIVE
  We investigated whether dietary supplementation of infants with eczema at age 3-6 months with Lactobacillus paracasei CNCM I-2116 or Bifidobacterium lactis CNCM I-3446 had a treatment effect or altered allergic disease progression.
  
  
  METHODS
  Primary outcome included eczema severity (SCORing Atopic Dermatitis, SCORAD) 3 months post-randomization. Secondary: SCORAD (other visits); infant dermatitis quality of life (IDQoL); gastrointestinal permeability; urinary eosinophilic protein X; allergen-sensitization; allergic symptoms (age 12, 18, 36 months). A total of 208 infants aged 3-6 months with physician-diagnosed eczema were recruited; 137/208 (SCORAD ≥ 10, consuming ≥ 200 mL standard formula/day) were randomized to daily supplements containing L. paracasei or B. lactis or placebo for a 3-month period, while receiving extensively hydrolysed whey-formula (dairy-free diet). There were two open observational groups, one group exclusively breastfed (n = 22) and the other, standard formula-fed (n = 49).
  
  
  BACKGROUND
  ISRCTN41490500.
  
  
  RESULTS
  Eczema severity decreased significantly over time in all groups. No significant difference was observed between randomized groups after 12-week treatment-period (SCORAD-score pre-/post-intervention: B. lactis 25.9 [95% CI: 22.8-29.2] to 12.8 [9.4-16.6]; L. paracasei 25.4 [22.1-29] to 12.5 [9.2-16.4]; placebo 26.9 [23.4-30.6] to 11.8 [9.6-14.3]; P = 0.7). Results were similar when analysis was controlled for allergen-sensitization, or when only sensitized infants were analysed. No differences were found for secondary outcomes. No difference was observed in SCORAD-score between randomized and observational groups.
  
  
  CONCLUSIONS
  We found no benefit from supplementation with B. lactis or L. paracasei in the treatment of eczema, when given as an adjunct to basic topical treatment, and no effect on the progression of allergic disease from age 1 to 3 years.
authors.affiliation: School of Translational Medicine, University of Manchester, NIHR Translational Research Facility in Respiratory Medicine, University Hospital of South Manchester NHS Foundation Trust, Manchester, UK. cgore@nhs.net
authors.forename: C
authors.initials: C
authors.lastname: Gore
authors.forename: A
authors.initials: A
authors.lastname: Custovic
authors.forename: G W
authors.initials: GW
authors.lastname: Tannock
authors.forename: K
authors.initials: K
authors.lastname: Munro
authors.forename: G
authors.initials: G
authors.lastname: Kerry
authors.forename: K
authors.initials: K
authors.lastname: Johnson
authors.forename: C
authors.initials: C
authors.lastname: Peterson
authors.forename: J
authors.initials: J
authors.lastname: Morris
authors.forename: C
authors.initials: C
authors.lastname: Chaloner
authors.forename: C S
authors.initials: CS
authors.lastname: Murray
authors.forename: A
authors.initials: A
authors.lastname: Woodcock
mesh_terms: D000328:Adult; D001644:Bifidobacterium / Q000276:immunology*; D002675:Child, Preschool; D003876:Dermatitis, Atopic / Q000276:immunology / Q000503:physiopathology / Q000517:prevention & control* / Q000628:therapy*; D019587:Dietary Supplements; D005260:Female; D006801:Humans; D007223:Infant; D007778:Lactobacillus / Q000276:immunology*; D008297:Male; D019936:Probiotics / Q000008:administration & dosage / Q000627:therapeutic use*; D011788:Quality of Life; D055502:Secondary Prevention; D012720:Severity of Illness Index; D016896:Treatment Outcome