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
Article first published online: 18 OCT 2011
© 2011 Blackwell Publishing Ltd
Clinical & Experimental Allergy
Volume 42, Issue 1, pages 112–122, January 2012
How to Cite
- Issue published online: 27 DEC 2011
- Article first published online: 18 OCT 2011
- Manuscript Accepted: 12 AUG 2011
- Manuscript Revised: 25 JUL 2011
- Manuscript Received: 20 JUN 2011
- Nestec Ltd
- Pharmacia Diagnostics
- Department of Clinical Biochemistry, Royal Manchester Children's Hospital
- North West Lung Research Centre Endowment Fund
- Nestec Ltd.
- allergic disease;
- quality of life;
- randomized double-blind placebo-controlled trial
Allergic disease has been associated with altered intestinal microbiota. Therefore, probiotics have been suggested as a potential treatment for eczema.
We investigated whether dietary supplementation of infants with eczema at age 3–6 months with Lactobacillus paracaseiCNCM I-2116 or Bifidobacterium lactisCNCM I-3446 had a treatment effect or altered allergic disease progression.
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). Trial number: ISRCTN41490500.
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.
Conclusion and Clinical Relevance
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.