Folster‐Holst 2006.
| Methods | Eight‐week parallel‐group randomised controlled trial from 2001 until 2002 | |
| Participants | Fifty‐four children 1 to 55 months of age with eczema diagnosed using Hanifin and Rajka criteria Setting: German Dermatology Centre Randomisation was done at a 1:1 ratio: 27 participants were randomised in each arm. Two‐centre trial. Six participants were lost to follow‐up, and 1 participant dropped out post randomisation but before treatment started |
|
| Interventions | Lactobacillus GG at 10¹º CFU/d as a twice‐daily dose, or microcrystalline cellulose placebo. Interventions given as capsules, which were mixed with milk if bottle fed, or mixed with water if not bottle fed | |
| Outcomes | • Parent global assessment of disease severity*
• Quality of life score (Ruden 1999)*
• SCORAD*
• Use of topical corticosteroid and systemic antihistamine treatment. Assessments made at 2, 4, 6, and 8 weeks after the start of the study* *Denotes outcomes prespecified for this review |
|
| Notes | Study was supported by InfectoPharm GmbH (Heppenheim, Germany) and Pharmacia GmbH (Freiburg, Germany) ‐ not related to probiotic "No conflicts of interest" declared |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "...randomly allocated" Comment: no concrete information on randomisation method ‐ inadequate for a judgement |
| Allocation concealment (selection bias) | Unclear risk | No information provided. Unable to assess the risk of bias |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quotes: "double blind..." ‐ "...placebo preparation (microcrystalline cellulose) with identical appearance" Comment: inadequate information for a judgement on risk of bias. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quotes: "double blind..." ‐ "...placebo preparation (microcrystalline cellulose) with identical appearance" Comment: inadequate information for a judgement on risk of bias |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Seven participants lost to follow‐up post randomisation (13%); of those, 1 after randomisation (not clear from which group) but before treatment started. Low rates of loss to follow‐up in both groups (15.4% in probiotic group and 7.4% in placebo). Available case analysis used without exclusions Comment: low incomplete data and judged as low risk for attrition bias for all outcomes |
| Selective reporting (reporting bias) | Low risk | No evidence of selective reporting found. All outcomes reported |
| Other bias | Low risk | No other bias found |