Ivankhnenko 2013.
| Methods | Eight‐week parallel‐group open‐label randomised placebo‐controlled trial | |
| Participants | Sixty full‐term infants 3 to 12 months of age with clinically diagnosed eczema and challenge proven cow's milk allergy, breast and formula fed. Randomisation was done at a 1:1 ratio: 30 participants were randomised in each arm. Excluded were patients who had received any probiotics within a month before recruitment and those with other allergies, severe comorbidities, and malformations Country: Ukraine 5 participants lost to follow‐up |
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| Interventions | Probiotic: Bifidobacterium lactis BB‐12 and Streptococcus thermophilus TH‐4 for 4 weeks No information on placebo Daily dose of probiotics: 1 × 10⁹ CFUs for BB‐12 and 1 × 10⁸ CFUs for TH‐4. Both groups on cow's milk elimination diet |
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| Outcomes | SCORAD at 4 and 8 weeks* *Denotes outcomes prespecified for this review |
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| Notes | No mention of sponsor. No declaration of conflicts of interest | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote from translated Russian article: "In this open label randomised prospective clinical study..." Comment: inadequate information for a judgement on risk of bias |
| Allocation concealment (selection bias) | Unclear risk | Inadequate information for assessment, so study judged as having unclear risk of bias |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label study |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Open‐label study |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Five participants lost to follow‐up (8%), with 2 participants from probiotic group (6.6%) and 3 participants (10%) from placebo group. Reasons for losses to follow‐up not given for each group. Not clear whether losses to follow‐up were excluded from analysis. However overall rates of loss to follow‐up were low and were unlikely to have a significant influence on effect estimates for study outcomes |
| Selective reporting (reporting bias) | Low risk | All outcomes reported |
| Other bias | Unclear risk | No mention of sponsor. No declaration of conflicts of interest |