Brouwer 2006.
| Methods | Three‐month parallel‐group randomised controlled trial | |
| Participants | Fifty‐one infants under 5 months age with mild/moderate eczema diagnosed using Hanifin and Rajka criteria, and a clinical history suggestive of cow's milk allergy. Randomisation was done at a 1:1 ratio: 17 participants were randomised in each arm (L rhamnosus, L GG, placebo). All participants were exclusively formula fed and received an extensively hydrolysed formula for 3 to 5 weeks before receiving the study intervention. Infants receiving antihistamines, oral corticosteroids, or any probiotic/antibiotic/antimycotic in the preceding 4 weeks were excluded, as were those with a congenital gastrointestinal malformation Setting: primary care in the Netherlands One participant lost to follow‐up |
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| Interventions | Extensively hydrolysed whey‐based formula given alone, with Lactobacillus rhamnosus at 5 × 10⁹ CFUs/100 mL or with Lactobacillus GG at 5 × 10⁹ CFUs/100 mL. The study formula was offered at all feeds during the intervention period | |
| Outcomes | SCORAD assessed at baseline, and at 1, 2, and 3 months* Total IgE, specific IgE to food mix (cow's milk, egg white, soy, peanut, cod, and wheat) and cow's milk, and skin prick test for cow's milk *Denotes outcomes prespecified for this review |
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| Notes | Study was funded by unrestricted grant from Numico Research, Wageningen, the Netherlands ‐ not related to probiotic. No information on conflicts of interest | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "all patients were randomised to either one of the study formulas..." Comment: no other information provided; method of randomisation not known |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "We conducted a randomised, double‐blind, placebo‐controlled study..." Comment: no further information provided; unclear whether blinding was adequate |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "We conducted a randomised, double‐blind, placebo‐controlled study..." Comment: no further information provided; unclear whether blinding was adequate |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Only 1 participant lost to follow‐up after randomisation; available case analysis without exclusions or imputation used |
| Selective reporting (reporting bias) | Low risk | No evidence of selective reporting found: all outcomes reported |
| Other bias | Low risk | No other bias found |