Nermes 2010.
| Methods | Three‐month parallel‐group randomised placebo‐controlled trial | |
| Participants | Thirty‐nine full‐term and otherwise healthy infants with atopic dermatitis diagnosed according to the Hanifin and Rajka criteria were recruited. Randomisation was done at a 1:1 ratio: 19 participants were randomised in the intervention arm, and 20 in the control arm. Patients with skin or other severe infections were excluded Recruitment was done at a paediatric secondary care setting in Finland Two participants were lost to follow‐up |
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| Interventions | Probiotic: Lactobacillus rhamnosus GG in extensively hydrolysed casein formula given at a dose of 5.0 × 10⁷ CFUs/gr, achieving a daily dose of 3.4 × 10⁹ CFUs/d for 3 months Placebo: extensively hydrolysed casein formula for 3 months |
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| Outcomes | • Total SCORAD* *Denotes outcomes prespecified for this review |
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| Notes | Study was partially funded by the formula manufacturer and a grant from the Academy of Finland. No conflicts of interest declared | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote from correspondence with study author: "the randomisation was carried out by the formula supplier (Mead Johnson, Evansville, IN, USA). The method used was block randomisation..." Comment: probably done; judged as adequate for low risk of bias |
| Allocation concealment (selection bias) | Unclear risk | No information given; inadequate information for a judgement |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote from correspondence with study author: "The study was a double‐blind, placebo controlled intervention study" ‐ "The information disclosing the codes of the study products was kept by a person not involved in the study and opened after the study was completed" Comment: probably done; judged as adequate for low risk of bias |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote from correspondence with study author: "The study was a double‐blind, placebo controlled intervention study" ‐ "The information disclosing the codes of the study products was kept by a person not involved in the study and opened after the study was completed" Comment: probably done; judged as adequate for low risk of bias |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Two participants lost to follow‐up, all from placebo group. Available case analysis unclear but very low rates of loss to follow‐up (5% in total and 10% in placebo group) unlikely to change the effect estimate. Reasons for losses to follow‐up given |
| Selective reporting (reporting bias) | Low risk | All outcomes reported |
| Other bias | Low risk | No other bias found |