Rosenfeldt 2003.
| Methods | Six‐week randomised controlled cross‐over trial | |
| Participants | Fifty‐eight children 1 to 13 years of age with eczema diagnosed using the UK Working Party Criteria. Children who had received systemic corticosteroids at any time were excluded Setting: hospital paediatric and dermatology departments in Denmark 15 participants lost to follow‐up |
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| Interventions | Skimmed milk powder with dextrose anhydrate 2 g/d or a mix of Lactobacillus rhamnosus 19070‐2 and Lactobacillus reuteri DSM12246 at 2 × 10¹º CFUs/d of each strain. Both placebo and probiotic preparations administered twice daily with 2.5 to 5 mL water | |
| Outcomes | • Global self‐assessment by participant or parent*
• SCORAD*
• Need for other treatment ‐ topical corticosteroid* *Denotes outcomes prespecified for this review |
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| Notes | Study was supported by Danish Research and Development Programme for Food Technology | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "The patients were randomised in a double‐blind crossover design...." ‐ "Blocked randomisation with 4 patients in each block was applied" Comment: inadequate information for a judgement on risk of bias |
| Allocation concealment (selection bias) | Unclear risk | No information provided. Inadequate information for a judgement |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "The patients were randomised in a double‐blind crossover design...." Comment: inadequate information for a judgement on risk of bias |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "The patients were randomised in a double‐blind crossover design...." Comment: inadequate information for a judgement on risk of bias |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Fifteen participants (25.9%) excluded from analysis. Five of these excluded during active treatment and 9 during placebo. Reasons for exclusion reported Comment: high rates of exclusion probably affecting all outcomes |
| Selective reporting (reporting bias) | Low risk | No evidence of selective reporting |
| Other bias | Low risk | No other bias found |