Cukrowska 2008.
| Methods | Eight‐month (3‐month intervention and 5‐month observation period) parallel‐group randomised double‐blind controlled trial | |
| Participants | Sixty children aged up to 24 months with atopic dermatitis diagnosed according to the criteria of Hanifin and Rajka (3 out of 4 major criteria had to be met) and with symptoms of cow's milk allergy were recruited. Randomisation was done at a 1:1 ratio: 29 participants were randomised in the intervention arm and 31 in the placebo arm. Participants and mothers of breast‐fed children had to be on a non‐dairy diet. Participants who had used antibiotics and probiotics within 6 months before recruitment were excluded from the trial. Recruitment took place at a secondary paediatric centre in Poland | |
| Interventions | Probiotic mixture: Lactobacillus casei LOCK 0900, Lactobacillus casei LOCK 08, Lactobacillus paracasei LOCK 0919 at a total daily dose of 10⁹ CFUs/d given orally for 3 months Placebo: hydrolysed casein given orally for 3 months |
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| Outcomes | Improvement vs exacerbation/no improvement based on SCORAD* • If SCORAD reduction > 2: improvement • If SCORAD reduction 0 to 2: lack of improvement • If SCORAD increased: deterioration *Denotes outcomes prespecified for this review |
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| Notes | Study financed by Ministry of Education grant | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote from translation from Polish: "The study carried out was randomised, double‐blinded..." Comment: no information provided on the random sequence generation method |
| Allocation concealment (selection bias) | Unclear risk | Quote from translation from Polish: "The study carried out was randomised, double‐blinded..." Comment: no information given on allocation concealment |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote from translation from Polish: "The study carried out was randomised, double‐blinded..." Comment: no information given on blinding method |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote from translation from Polish: "The study carried out was randomised, double‐blinded..." Comment: no information given on blinding method |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 29% of participants in probiotic group and 32% in placebo group lost to follow‐up at the end of the intervention Comment: losses to follow‐up similar in both groups but high in both and may have influenced the outcome of short‐term change in global eczema severity; no information provided on whether available case analysis was used. No reasons for losses to follow‐up given |
| Selective reporting (reporting bias) | Low risk | All outcomes reported as predefined |
| Other bias | Low risk | No other bias found |