Weston 2005.

Methods	Eight‐week parallel‐group block randomised controlled trial
Participants	Fifty‐six children 6 to 18 months of age with moderate/severe eczema diagnosed by Hanifin and Rajka criteria and modified SCORAD score of at least 25 at enrolment Randomisation was done at a 1:1 ratio: 28 participants were randomised in each arm. Those previously exposed to probiotics, currently receiving antibiotics, or with other major medical problems were excluded Setting: community and hospital outpatient clinic in Australia Three participants lost to follow‐up
Interventions	Lactobacillus fermentum VR1‐003PCC 2 × 10⁹ CFUs/d as a sachet reconstituted by parents with 5 to 10 mL water twice daily, or maltodextrin placebo
Outcomes	• Global self‐assessment by parent* • Dermatitis Family Impact Questionnaire (Lawson 1998)* • SCORAD* • Need for other eczema treatment ‐ topical corticosteroid. Assessments made at baseline and at 2, 4, 8, and 16 weeks* *Denotes outcomes prespecified for this review
Notes	One probiotic‐treated participant withdrew due to gastrointestinal illness (vomiting) Funding for principal investigator was provided by Research Fellowship by television channel and funding for IgE assay by VRI Biomedical. Probiotics and placebo supplied by manufacturer. No conflicts of interest declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "A computerised randomisation schedule was prepared by the hospital biostatistician with allocation and dispensing of sachets by the pharmacy department" ‐ "The groups were stratified and block randomised according to following criteria: (a) modified SCORAD (25‐50; 50 and over), (b) current topical corticosteroid potency.... and (c) age..." Comment: judged as adequate for low risk of bias
Allocation concealment (selection bias)	Low risk	Quote: "A computerised randomisation schedule was prepared by the hospital biostatistician with allocation and dispensing of sachets by the pharmacy department. The probiotic and placebo sachets were matched for size, shape and volume of contents" Comment: third party involved in the allocation process and interventions were identical. Judged as adequate for low risk of bias
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quotes: "The probiotic and placebo sachets were matched for size, shape and volume of contents" ‐ "A SCORAD assessment was also performed by a clinician blind to the intervention" ‐ "...a single investigator performed all SCORAD assessments at week 0, 8, and 16" Comment: outcome assessor clearly stated as blinded and interventions probably identical. However no other information provided to clarify whether other personnel and the parents of infants were blinded
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quotes: "The probiotic and placebo sachets were matched for size, shape and volume of contents" ‐ "A SCORAD assessment was also performed by a clinician blind to the intervention" ‐ "...a single investigator performed all SCORAD assessments at week 0, 8, and 16" Comment: outcome assessor clearly stated as blinded and interventions probably identical. However no other information provided to clarify whether other personnel and the parents of infants were blinded, which may have affected patient/parent‐reported outcomes (DFI and global self‐assessment)
Incomplete outcome data (attrition bias) All outcomes	Low risk	Available case analysis was used without exclusions after randomisation. Low rates of loss to follow‐up (5.4% overall; 7.1% in probiotic group and 3.6% in placebo group). Reasons for losses to follow‐up presented Low risk of attrition bias for all outcomes
Selective reporting (reporting bias)	Low risk	No evidence of selective reporting
Other bias	Low risk	No other bias found