Shafiei 2011.
| Methods | Parallel‐group double‐blind placebo‐controlled randomised trial conducted between December 2008 and November 2009 | |
| Participants | Forty‐one children from 1 to 36 months of age with moderate to severe (SCORAD > 25) atopic dermatitis diagnosed according to Hanifin and Rajka criteria were recruited. Randomisation was done at a 1:1 ratio: 20 participants were randomised in the intervention arm, and 21 in the control arm. Exclusion criteria were administration of systemic steroids, recurrent infection, evidence of immunodeficiency, congenital abnormality, chronic disease, and problems in eating. Five participants were lost to follow‐up Setting: Iranian Paediatric Allergy and Immunology Department |
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| Interventions | Synbiotic: 7‐strain probiotic and synbiotic in a sachet given daily at a dose of 1 × 10⁹ CFUs of probiotic and 990 mgr of fructo‐oligosaccharide for 2 months (59 days) Placebo: sucrose in a 1000‐mgr sachet given daily for 2 months (58 days) Both interventions were prepared by mixing with water, breast milk, formula, or solid food |
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| Outcomes | Total and objective SCORAD changes from baseline to end of intervention after 2 months* *Denotes outcomes prespecified for this review |
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| Notes | Sponsorship is unclear. Conflicts of interest are not declared | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Randomisation was performed according to a computer‐generated balanced block randomisation to synbiotic and placebo groups" Comment: judged as adequate for low risk of bias |
| Allocation concealment (selection bias) | Unclear risk | Quote: "At enrolment we assigned the study number and provided the participants with the appropriate sachet" Comment: not clear whether allocation to a treatment could have been predicted |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | It is stated: "Partcipants and investigators blinded for the duration of the trial" ‐ "Placebo and intervention image‐matched and identical in appearance, taste and smell" Comment: judged as adequate for low risk of bias |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | It is stated: "Partcipants and investigators blinded for the duration of the trial", but no specific information provided on outcome assessor Comment: judged as unclear risk due to lack of specific information |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Five participants out of 41 (12%) were lost to follow‐up: 2 participants were from the probiotic group (10%) and 3 from the placebo group (14%). Reasons for loss to follow‐up were given and were similar in both groups. Case analysis was available. Low rates of loss to follow‐up unlikely to have a significant impact on the effect estimate |
| Selective reporting (reporting bias) | Unclear risk | Baseline characteristics and outcomes reported only for participants who completed the trial. Unclear whether groups were matched at baseline |
| Other bias | Unclear risk | Sponsorship unclear |