Farid 2011.
| Methods | Eight‐week parallel‐group double‐blind placebo‐controlled randomised trial conducted between November 2007 and March 2009 | |
| Participants | Fifty‐two children from 3 months to 6 years of age with mild to severe atopic dermatitis. Randomisation was done at a 1:1 ratio, but no exact numbers were given for randomised participants in each arm. Patients who had prior exposure to probiotics, or who were at the time taking antibiotics, or who had major medical problems, were excluded from the trial. Twelve patients were lost to follow‐up Setting: secondary care, paediatric Allergy and Immunology Department in Iran |
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| Interventions | Synbiotic mixture: Lactobacillus casei, Lactobacillus rhamnosus, Streptococcus thermophilus, Bifidobacterium breve, Lactobacillus acidophilus, Bifidobacterium infantis, Lactobacillus bulgaricus, and fructo‐oligo‐saccharide in 1‐gram sachets dissolved in water or breast milk, at a dose of 1 × 10⁹ CFUs/g twice daily for 8 weeks. Placebo not specified | |
| Outcomes | SCORAD change from baseline to 4 and 8 weeks and from 4 to 8 weeks* *Denotes outcomes prespecified for this review |
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| Notes | "No conflicts of interest" declared but funding not declared; probiotic provided by the manufacturer | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Participants were randomly divided into two groups..." Comment: no other information provided; method of randomisation unknown; therefore unclear risk of bias |
| Allocation concealment (selection bias) | Unclear risk | Quote: "Participants were randomly divided into two groups..." Comment: unclear whether allocation was concealed; no more information provided |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participant: "placebo powder was matched for size, shape and volume of contents" Clinicians: "this randomised, double blind, placebo controlled trial..." ‐ "SCORAD index assessment was performed by a single clinician who was blinded to intervention" Comment: risk of bias unclear regarding blinding of personnel allocating participants to treatment; no relevant information |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "SCORAD index assessment was performed by a single clinician who was blinded to intervention" ‐ "placebo powder was matched for size, shape and volume of contents" ‐ "placebo powder was matched for size, shape and volume of contents" Comment: blinding of participants and investigators who assess the global eczema severity score (the only clinical outcome of this study) judged to be adequate; therefore study judged to be of low risk of detection bias |
| Incomplete outcome data (attrition bias) All outcomes | High risk | High rate of losses to follow‐up: 12 participants (23%) lost to follow‐up and excluded from analysis. We judged this to lead to high risk of attrition bias. Not clear whether rates of loss to follow‐up were similar in both groups. Reasons for loss to follow‐up given, but treatment group from which losses occurred not specified |
| Selective reporting (reporting bias) | Unclear risk | Twelve participants (23%) lost to follow‐up and excluded from analysis. Baseline characteristics and outcomes reported only for participants completing the trial. Unclear whether reporting only characteristics of participants can lead to reporting bias. Trial registered in the Iranian Registry for Clinical Trials retrospectively, and number of participants registered pertains to those who completed the study only. Unclear risk of bias, as not clear whether this could have influenced the outcome for global eczema severity |
| Other bias | Unclear risk | "No conflicts of interest" declared, but not the funding. Probiotic provided by the manufacturer |