Wu 2015.
Methods | Eight‐week parallel‐group 2‐centre randomised double‐blind placebo‐controlled trial | |
Participants | Sixty‐seven children 4 to 48 months of age with atopic dermatitis diagnosed using Hanifin‐Rajka criteria with SCORAD > 15 at enrolment. Randomisation was done at a 1:1 ratio: 34 participants were randomised in the intervention arm, and 33 in the control arm Exclusion criteria: clinically evident infection in skin lesions, severe asthma or acute asthma attack within 3 months, autoimmune disease, immunodeficiency, exposure to phototherapy, use of systemic corticosteroids within 1 month |
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Interventions | Active: 1 capsule of ComProbi containing 350 mg ofLactobacillus rhamnosus (MP108) and maltodextrin per day Control: 1 capsule of maltodextrin per day If capsule could not be swallowed, parents were instructed to mix the powder in water, breast milk, milk, or food heated to < 40°C Rescue medication: Cutivate cream (GlaxoSmithKline, Duhram, UK) in cases of uncontrolled symptoms |
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Outcomes | Primary • Change in SCORAD after 8‐week treatment Secondary • Change in SCORAD at post‐baseline visits • Frequency and total quantity of corticosteroids used during 8‐week treatment • Comparison of frequency of atopic dermatitis and symptom‐free duration • Comparisong of mean changes from baseline in IDQoL at weeks 4 and 8 • Comparisong of mean changes from baseline on Dermatitis Family Impact Questionnaire at weeks 4 and 8 |
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Notes | Contact: cshy095@csh.org.tw Country: Taiwan Study registration not given CY Biotech provided probiotic, but it is not clear whether the company had a role in study design, data analysis, or interpretation or other aspects of the study. However, study authors declared no conflicts of interest |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Inadequate information provided; stated that the study was "randomised" |
Allocation concealment (selection bias) | Unclear risk | No information provided |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Study stated as "double‐blind", but no information provided to explain who was blinded and how blinding was done |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Study stated as "double‐blind", but no information provided to explain who was blinded and how blinding was done |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 3 (9%) from the probiotic arm and 1 (3%) from the control arm Study authors present data derived from intention‐to‐treat analysis |
Selective reporting (reporting bias) | Unclear risk | All predefined outcomes were at least described, but not all data were given. No clinical trial registration was given |
Other bias | Unclear risk | CY Biotech provided probiotic, but it is not clear whether the company had a role in study design, data analysis or interpretation, or other aspects of the study. However study authors declared no conflict of interest Hence we judged the study to be at unclear risk of commercial bias |