Viljanen 2005.
| Methods | Four‐week parallel‐group randomised controlled trial | |
| Participants | 252 infants younger than 12 months of age with a clinical diagnosis of eczema and a clinical history suggestive of cow's milk allergy. Randomisation was done at a 1:1 ratio: 84 participants were randomised in each arm. Infants who had received a probiotic preparation for over a week in the preceding 6 weeks were excluded Participants were selected from primary care referrals to a hospital clinic in Finland Twenty‐two participants were lost to follow‐up |
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| Interventions | Cow's milk elimination diet, extensively hydrolysed formula, and capsules of microcrystalline cellulose placebo, Lactobacillus GG (10¹º CFUs/d), or probiotic mix (Lactobacillus GG 10¹º CFUs/d, Bifidobacterium breve Bbi 99 4 × 10⁸ CFUs/d,Lactobacillus rhamnosus LC705 10¹º CFUs/d, and Propionibacterium JS 4 × 10⁹ CFUs/d). Capsules were mixed with food twice daily | |
| Outcomes | SCORAD assessed at end of treatment and 4 weeks later* *Denotes outcomes prespecified for this review |
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| Notes | Study was supported by Finnish Research foundations and the probiotic supplier. No information on conflicts of interest | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Infants were randomised at the first visit according to computer‐generated block randomisation..." Comment: judged as adequate for low risk of bias |
| Allocation concealment (selection bias) | Low risk | Adequate: treatment allocated by third party as confirmed by study author |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants and clinician blinded as confirmed by study author |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessor blinded as confirmed by study author |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Analysis was by "treatment received", and 4 participants (1.6%) were excluded from analysis because they did not tolerate the study formula. Twenty‐two (8.7% to 5.9% in LGG group, 10.6% in probiotic mix group, and 9.75% in placebo group) losses to follow‐up occurred. Unlikely to have an impact on effect estimate and judged as having low risk of attrition bias |
| Selective reporting (reporting bias) | Low risk | No evidence of selective reporting |
| Other bias | Unclear risk | Study was supported by Finnish Research foundations and the probiotic supplier. Not clear whether the probiotic supplier had any influence on data analysis |