Gerasimov 2010.

Methods	Eight‐week parallel‐group randomised double‐blind placebo‐controlled trial held between June 2007 and June 2008
Participants	Ninety‐six children between 1 and 3 years of age with moderate to severe atopic dermatitis diagnosed according to the criteria of Hanifin and Rajka were recruited Randomisation was done at a 1:1 ratio: 48 participants were randomised in each arm. Only patients whose parents or legal guardians had the ability to comprehend the study requirements and to provide informed consent and those with direct telephone access were recruited Patients with clinically evident bacterial skin lesions, chronic concomitant disease that would likely require use of immunosuppression or antihistamines during research period, presence of severe systemic disease or cancer at any site and stage, suspected or established primary/secondary immune deficiency, and food allergy other than egg or cow’s milk were excluded from the study. Also excluded were patients with mild disease and those currently taking systemic corticosteroids Six participants were lost to follow‐up Recruitment took place at a paediatric secondary care unit in Ukraine
Interventions	Synbiotic: mixture of Lactobacillus acidophilus DDS‐1 and Bifidobacterium lactis UABLA‐12 with fructo‐oligosaccharide in a rice maltodextrin powder given twice daily reconstituted in tepid water or juice or baby food and immediately fed for 8 weeks. Dose given: 5 × 10⁹ CFU/gr for the 2 probiotics and 50 mgr/gr of fructo‐oligosaccharide Placebo: rice maltodextrin powder only given twice daily reconstituted in tepid water or juice or baby food and immediately fed for 8 weeks Parents were given 140 doses of the intervention and were asked to give 112 doses in total Treatment of atopic dermatitis during intervention: skin hydration, emollients, avoidance of allergens and irritants according to PRACTALL (Practical Allergology) recommendations. Hydrocortisone 1% or Mometasone 0.1% ointment was allowed as rescue medication. Elimination diet for 2 months before and during trial period. Diet was cow's milk or egg free, depending on which food allergy the participant had. No elimination diet for participants without food allergies
Outcomes	• IDQoL changes at 4 and 8 weeks* • DFI at 4 and 8 weeks* • SCORAD parts A, B, and C at 2, 4, and 8 weeks* • Frequency of topical corticosteroid use (days per week) at 8 weeks* • Cumulative use of topical corticosteroids during intervention period* *Denotes outcomes prespecified for this review
Notes	Study was funded by the Lviv National Medical University of Ukraine. "No conflicts of interest" declared Twenty‐six participants in the probiotic group (60.5%) and 24 in the placebo group (51.1%) developed adverse effects: upper respiratory tract infection, lower respiratory tract infection, herpetic stomatitis, diarrhoea, constipation, abdominal colic. Two children in the probiotic group (4.7%) and 3 in the placebo group (6.4%) experienced severe adverse events (head injury and food poisoning) that were reported to be unrelated to the intervention under investigation
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "patients were randomised using computer‐generated random codes to receive either probiotic or placebo treatment" Comment: judged as adequate for low risk of bias
Allocation concealment (selection bias)	Unclear risk	Inadequate information; study judged to be at unclear risk of bias
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "probiotic and placebo were identical in appearance, taste, smell, packing and manner of administration. All formulations were dispensed by a technician with investigator and patient blinded regarding the identity of the treatment" Comment: judged as adequate for low risk of performance bias
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "probiotic and placebo were identical in appearance, taste, smell, packing and manner of administration. All formulations were dispensed by a technician with investigator and patient blinded regarding the identity of the treatment" Comment: judged as having unclear risk of bias; no information on blinding of outcome assessor
Incomplete outcome data (attrition bias) All outcomes	Low risk	Six participants lost to follow‐up (6.25%): 5/48 (10%) in the probiotic group and 1/48 (2%) in the placebo group. Reasons for losses to follow‐up given: intercurrent illness (2 in probiotic and 1 in placebo group, 1 protocol violation in probiotic group and 1 diet deviation in probiotic group). Participants analysed in the group to which they were randomised Comment: judged as low risk, as rates for follow up are low and were unlikely to have influenced outcomes
Selective reporting (reporting bias)	Low risk	All outcomes reported
Other bias	Low risk	No other bias found