Efficacy of probiotics combined with tacrolimus ointment in children with atopic dermatitis and its effects on serum IgE, IL-4, and LTB4: A single-center retrospective cohort study.
Adjunctive use of a specified probiotic formulation with tacrolimus ointment was associated with greater short-term improvement in atopic dermatitis than tacrolimus-based care alone, though the between-group difference was smaller than the minimal clinically important difference and residual confounding cannot be excluded.
Key Findings
Results
The combination group had a greater mean reduction in SCORAD than the tacrolimus-only group in the original cohort.
Mean SCORAD reduction was 29.2 ± 10.4 in the combination group versus 23.7 ± 11.0 in the tacrolimus-only group.
Unadjusted between-group difference was 5.5 points (P = .004).
The 5.5-point difference was smaller than the commonly cited 8.7-point within-patient minimal clinically important difference for SCORAD.
Study included 92 children with atopic dermatitis treated between March 2023 and March 2025.
Results
The clinical response rate (≥50% reduction in SCORAD at week 12) was higher in the combination therapy group than in the tacrolimus-only group.
Response rate was 82.6% in the combination group versus 60.9% in the tacrolimus-only group.
Unadjusted difference in response rates was statistically significant (P = .018).
Primary outcomes were assessed at week 12.
Results
Propensity score matching confirmed the association between combination therapy and clinical response after accounting for measured baseline differences.
A 1:1 nearest-neighbor propensity score matching produced 38 matched pairs.
All post-matching standardized mean differences (SMDs) were <0.10, indicating adequate covariate balance.
Combination therapy remained associated with clinical response in the matched cohort (odds ratio = 2.76, 95% CI = 1.05–7.27; P = .039).
Propensity scores were estimated from age, sex, disease duration, baseline SCORAD, baseline total IgE, physician-diagnosed food allergy, and passive smoking exposure.
Results
A multivariable model with additional adjustment for food allergy and passive smoking produced a consistent estimate of the treatment association.
Adjusted odds ratio was 2.91 (95% CI = 1.16–7.31; P = .022).
Additional covariates adjusted for were food allergy and passive smoking exposure.
The consistency of the estimate across analytical approaches supports robustness to measured baseline differences.
Methods
The study design was a single-center retrospective cohort, and residual and unmeasured confounding cannot be excluded.
Treatment exposure reflected routine clinical practice rather than randomization.
Propensity score matching was described as a 'simulated' sensitivity analysis.
The authors note that 'prospective randomized studies with longer follow-up are required.'
Caliper width for matching was 0.2 standard deviations of the logit of the propensity score.
Methods
The study assessed effects on serum total immunoglobulin E (IgE), interleukin-4 (IL-4), and leukotriene B4 (LTB4) as secondary outcomes.
Serum total IgE, IL-4, and LTB4 were evaluated as part of the outcome assessments.
Baseline total IgE was among the variables used to estimate propensity scores, indicating it differed or could differ between groups at baseline.
Specific post-treatment biomarker values are not reported in the abstract.
What This Means
This research suggests that adding a probiotic supplement to tacrolimus ointment (a standard skin treatment) may improve outcomes in children with atopic dermatitis, commonly known as eczema, compared to using tacrolimus alone. In a group of 92 children, those who received the combination treatment showed a larger reduction in disease severity scores and were more likely to achieve a meaningful clinical response — defined as at least a 50% improvement — after 12 weeks of treatment. The response rate was 82.6% in the combination group compared to 60.9% in the tacrolimus-only group.
Because this was a retrospective study (looking back at existing medical records rather than randomly assigning treatments), the researchers used a statistical technique called propensity score matching to try to account for differences between patients who received the two treatments. After this adjustment, the benefit of combination therapy remained statistically significant. However, the actual difference in improvement scores between the two groups (5.5 points) was smaller than what is generally considered a clinically meaningful change for an individual patient (8.7 points), meaning the practical significance of this difference is uncertain.
This research suggests that probiotics may offer some added benefit when used alongside tacrolimus in pediatric eczema, but the findings should be interpreted with caution. The study's retrospective design means it cannot rule out other factors that might explain the difference in outcomes, and the treatment benefit, while statistically detectable, was modest. The authors emphasize that randomized controlled trials with longer follow-up periods are needed before firm conclusions can be drawn.
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Zhu J, Bu D. (2026). Efficacy of probiotics combined with tacrolimus ointment in children with atopic dermatitis and its effects on serum IgE, IL-4, and LTB4: A single-center retrospective cohort study.. Medicine. https://doi.org/10.1097/MD.0000000000050451