Iemoli 2012.
| Methods | Twenty‐week parallel‐group double‐blind placebo‐controlled randomised trial from April until September 2010 | |
| Participants | 48 adults between 18 and 55 years of age with moderate to severe atopic dermatitis diagnosed according to "Consensus guidelines in diagnosis and treatment of atopic dermatitis" (Eichenfield 2004). Participants were randomised at a 2:1 intervention:control ratio (32 participants in intervention arm/16 participants in control arm). Patients who had taken probiotics in the 6 months before enrolment, or topical immunomodulators, corticosteroids, or antihistamines; who had chronic disease, congenital or acquired immunosuppression, acute or chronic infection, or allergic contact dermatitis; and pregnant or lactating patients were excluded from the trial. Also excluded were patients who were on elimination diets without a known food allergy and those with hypersensitivity to the components of the probiotics Participants were recruited at a secondary Immunology centre in Italy Two participants were lost to follow‐up |
|
| Interventions | Mixture of probiotics in maltodextrin: Lactobacillus salivarius LS01 DSM 2275, Bifidobacterium breve BR03 DSM 16604, given twice daily at a dose of 1 × 10⁹ CFUs/gr for each probiotic for 12 weeks Placebo: maltodextrin given only twice daily for 12 weeks |
|
| Outcomes | • DLQI at baseline and at 12 and 20 weeks* • SCORAD at baseline and at 12 and 20 weeks* *Denotes outcomes prespecified for this review |
|
| Notes | "No conflicts of interest" declared. No information on funding. Probiotics provided by the manufacturer | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "patients were randomised with a 2:1 ratio..." Quote from communication with study author: "A computerized randomisation schedule was prepared..." Comment: judged as adequate for low risk of bias |
| Allocation concealment (selection bias) | Low risk | Quote from communication with study author: "allocation and dispensing by blind clinical investigator" Comment: judged as adequate for low risk of bias |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Probiotic and placebo sachets were matched for size, shape and volume of contents" Quote from communication with study author: "allocation and dispensing by blind clinical investigator" Comment: judged as adequate for low risk of bias |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "A single investigator blinded to the treatment arm, performed all SCORAD assessments..." Comment: judged as adequate for low risk of bias |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Low rates of loss to follow‐up (4%) overall. 1 participant lost to follow‐up in each arm: 3% in probiotic group and 6% in placebo group. Different reasons for losses to follow‐up given but overall low rates unlikely to have a significant influence on effect estimates for all outcomes |
| Selective reporting (reporting bias) | Low risk | All outcomes reported |
| Other bias | Unclear risk | "No conflicts of interest" declared. Unavailable information on funding. Probiotics provided by the manufacturer |