Kirjavainen 2003.
| Methods | Parallel‐group randomised controlled trial. Intended duration of treatment not clear | |
| Participants | Twenty‐seven infants (mean age 5.5 months) with eczema and suspected cow's milk allergy. Method for diagnosing eczema not described Setting: hospital paediatric department in Finland Unclear how many participants lost to follow‐up Participants randomised 2:1, probiotic:control |
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| Interventions | Lactobacillus GG at 3 × 10¹º CFUs/kg/d, mixed with extensively hydrolysed whey formula, or the same formula without probiotic. A third treatment arm (excluded from this review) used heat‐inactivatedLGG at 3 × 10¹º CFUs/kg/d, mixed with extensively hydrolysed whey formula | |
| Outcomes | SCORAD* *Denotes outcomes prespecified for this review |
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| Notes | Study terminated early due to adverse effects in a third treatment arm. Third treatment arm not included in this systematic review because it involved the use of killed bacteria Study funded by the Academy of Finland |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "These infants were randomly assigned into placebo, viable LGG..." Comment: inadequate information for a judgement on risk of bias |
| Allocation concealment (selection bias) | Unclear risk | No information reported. Inadequate information for a judgement on risk of bias |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "These infants were randomly assigned into placebo, viable LGG or heat‐inactivated LGG groups and accordingly given in a double blind manner..." Comment: inadequate information for a judgement on risk of bias |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "These infants were randomly assigned into placebo, viable LGG or heat‐inactivated LGG groups and accordingly given in a double blind manner..." Comment: inadequate information for a judgement on risk of bias |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No data given on losses to follow‐up. Inadequate information for a judgement on risk of bias |
| Selective reporting (reporting bias) | Low risk | No evidence of selective reporting |
| Other bias | Low risk | No other bias found |