The autoimmune condition known as immune thrombocytopenia (ITP) is typified by a reduction in platelet formation and an increase in platelet breakdown. This study investigated the potential of probiotics as adjuvant therapy to improve platelet counts and bleeding scores in children with newly diagnosed ITP [1]. Live microorganisms known as probiotics, which include yeast and bacteria, have been demonstrated to enhance human health.

The microbiome has a multifaceted impact on our health and illness state. It has the ability to cause or alter neurodegenerative, auto-immunogenic, and metabolic illnesses. It also modifies medication interactions and hosts immune response regulation [12].

The gut microbiota of many autoimmune diseases was altered and even was identified as one of the etiologies. In the human gut, there are over a thousand different types of bacteria that are involved in both health and illness. This implies that the pathophysiology of primary ITP may include the gut microbiota [13].

To the best of our knowledge, this randomized controlled trial evaluating probiotics as adjuvant therapy in pediatric ITP is the first of its kind. While direct comparisons with similar ITP studies are unavailable, our findings align with research on probiotics in other autoimmune conditions.

In the current study, we enrolled 30 ITP patients in the control group (group I) corresponding to 30 patients in the probiotics group (group II) with a median age of 5 (1–16) years.

In terms of clinical and demographic traits, the two groups were well-matched, and no statistically significant differences were found in any of the variables that were displayed. Although there was no statistically significant difference (p = 0.098), the median age of the probiotics group seemed to be greater (7 years) than that of the control group (4 years).

Our findings demonstrate a significant improvement in platelet counts in the probiotics group compared to the control group at both 6 and 12 months, suggesting that probiotics may offer long-term benefits in promoting platelet recovery. This aligns with previous research indicating the gut microbiota’s role in immune regulation and its potential modulation by probiotics. Our results are consistent with the growing body of evidence supporting the immunomodulatory effects of probiotics in autoimmune diseases.

The significant improvement in platelet counts at 6 and 12 months in the probiotics group parallels the immunomodulatory effects observed by Yazdandoustet al. [14] in their study on graft-versus-host disease (GVHD). Their finding of increased CD4⁺CD25⁺FoxP3⁺ regulatory T cells with probiotic therapy is particularly relevant, as ITP pathophysiology involves T cell imbalance and reduced regulatory T cells (Tregs). This suggests a possible mechanism for our observed improvements in platelet counts.

As for the bleeding score, the probiotics group showed a statistically significant improvement in bleeding score compared to the control group (p = 0.002). The results of our study suggested a potential long-term benefit of probiotics intervention on platelet recovery and bleeding score in ITP.

Our findings of improved clinical outcomes align with Mehrabany et al. [15] research in rheumatoid arthritis, where probiotic supplementation significantly reduced pro-inflammatory cytokines (TNF-α, IL-6, IL-12) and increased the regulatory cytokine IL-10. Since pro-inflammatory cytokines interfere with megakaryocyte maturation and platelet release in ITP, the cytokine-modulating effects of probiotics may explain the observed improvements in platelet counts.

Additionally, the significant improvement in bleeding scores in the probiotics group (p = 0.002) reflects similar positive clinical outcomes seen in other autoimmune conditions. For example, Francavilla et al. [16] observed improvements in celiac disease, and Kouchaki et al. [17] reported enhanced efficacy of interferon-β therapy and reduced disability in multiple sclerosis patients. The latter study’s improvement in Expanded Disability Status Scale (EDSS) scores (p = 0.001) with probiotic therapy particularly mirrors our positive clinical outcomes.

Regarding safety, our finding of no significant differences in side effects between groups (p = 0.94) addresses concerns raised by Lerner et al. [18] about probiotic safety. In fact, the probiotics group showed a higher percentage of patients with no side effects (63.33% vs. 53.33% in controls), suggesting good tolerability.

While our study showed no statistically significant differences in early, initial, and durable responses between groups, the significant improvements in long-term platelet counts and bleeding scores suggest a cumulative beneficial effect of probiotic therapy over time. This pattern aligns with Zamani et al. [19] findings in rheumatoid arthritis, where sustained probiotic supplementation led to improved disease activity scores.

Other studies have shown that probiotics can influence immune responses by altering cytokine production and T-cell activity, which could contribute to the observed increase in platelet counts [19, 20].

Moreover, our study revealed a statistically significant improvement in bleeding scores in the probiotics group at 1 month. This early improvement in bleeding symptoms could be attributed to the faster platelet recovery observed in the probiotic group, although the difference in early response rates was not statistically significant. The reduction in bleeding scores is clinically relevant as it indicates a decreased risk of bleeding complications.

While the exact mechanisms by which probiotics exert their beneficial effects in ITP are not fully elucidated, several possibilities exist. Probiotics may enhance intestinal barrier function, reducing inflammation and immune activation [21, 22]. They may also modulate the immune response by influencing cytokine production and T-cell differentiation, potentially leading to a decrease in autoantibody production and platelet destruction [23, 24]. Further research is needed to explore these mechanisms in detail.