Passeron 2006.
| Methods | Three‐month parallel‐group randomised controlled trial | |
| Participants | Forty‐eight children 2 to 12 years of age with moderate/severe eczema diagnosed by UK Working Party Criteria and total SCORAD over 14. Randomisation was done at a 1:1 ratio: 24 participants were randomised in each arm. Exclusion criteria included current flare of eczema, exposure to systemic corticosteroids or immunosuppressants in the previous 3 months, and other known immune deficiency Setting: hospital dermatology clinic in France Nine participants lost to follow‐up |
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| Interventions | Skim milk powder, potato starch, and lactose‐containing prebiotic, with or without Lactobacillus rhamnosus Lcr35 at 3.6 × 10⁹ CFUs/d, given as a 3‐times‐daily dose mixed with cold water or other liquid | |
| Outcomes | • Parent or participant global assessment of eczema severity*
• SCORAD*
• Investigator global assessment of eczema severity*
Assessments were done at baseline and at 1, 2, and 3 months *Denotes outcomes prespecified for this review |
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| Notes | Three episodes of mild abdominal pain reported ‐ 2 in probiotic group, 1 in placebo (prebiotic alone) group Funding and conflict of interest not reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation sequence as confirmed by study authors. Judged as having low risk of bias |
| Allocation concealment (selection bias) | Low risk | Adequate as confirmed by study authors and judged as having low risk |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "The patients, their parents and the dermatologists were blinded to the treatment the patient was receiving" ‐ "Each patient was examined by the same dermatologist at each visit" Study authors confirmed blinding of all parties in the trial Comment: probably done and judged as adequate for low risk of bias |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The patients, their parents and the dermatologists were blinded to the treatment the patient was receiving" "Each patient was examined by the same dermatologist at each visit" Study authors confirmed blinding of all parties in the trial Comment: probably done and judged as adequate for low risk of bias |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Available case analysis used without exclusions after randomisation with low total rates of loss to follow‐up (18.7%). Losses to follow‐up per group: 29% in synbiotic group and 8% in placebo group. Reasons for losses in the synbiotic group were non‐attendance at follow‐up visits (5/24 participants) and withdrawal of consent (2/24). In the prebiotic group, 2/24 participants did not attend for follow‐up Significant differences in rates of loss to follow‐up in the 2 groups, which probably had an impact on all outcomes |
| Selective reporting (reporting bias) | Low risk | No evidence of selective reporting |
| Other bias | Unclear risk | Funding and conflict of interest not reported |