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Background <p>Among the most commonly observed bleeding disorders in children is immune thrombocytopenia (ITP). Many autoimmune diseases have been successfully treated with probiotics, which can also play a role in the regulation of immune responses. This study was conducted to assess the impact of probiotics as&#xa0;adjunct treatment for children with newly diagnosed ITP.</p> Methods <p>This randomized controlled trial was conducted on 60 children with newly diagnosed ITP who were allocated into 2 groups, group I the control group (<i>n</i> = 30), receiving standard corticosteroid therapy (prednisone 2&#xa0;mg/kg/day for 1&#xa0;week), group II the probiotic group (<i>n</i> = 30), receiving standard corticosteroid therapy (prednisone 2&#xa0;mg/kg/day for 1&#xa0;week)&#xa0;plus probiotics (Bacillus clausii, 2 billion/5&#xa0;ml daily for 2&#xa0;weeks). Platelet counts, bleeding scores, and side effects were assessed over a 12-months follow-up period.</p> Results <p>The probiotic group showed significantly higher platelet counts at 6 and 12&#xa0;months compared to the control group (<i>p</i> &lt; 0.01). The probiotic group also demonstrated significantly greater improvement in bleeding scores at 1&#xa0;month (<i>p</i> = 0.002). Complete response rates, early, initial, durable responses, and remission rates were numerically higher in the probiotic group but did not reach statistical significance. No significant differences in side effect profiles were observed between the two groups.</p> Conclusions <p>Probiotic supplementation as an adjuvant to standard corticosteroid therapy may improve long-term platelet recovery and bleeding scores in children with newly diagnosed ITP.</p> Trial registration <p>PACTR202311873054587.</p>

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Role of probiotics as adjuvant therapy in newly diagnosed immune thrombocytopenia in children: a randomized controlled trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年4月1日

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  • Soma Mansour,
  • Mohammed Elshanshory,
  • Lamia Morad,
  • Rasha Elkholy,
  • Eman Elaskary

摘要

Background

Among the most commonly observed bleeding disorders in children is immune thrombocytopenia (ITP). Many autoimmune diseases have been successfully treated with probiotics, which can also play a role in the regulation of immune responses. This study was conducted to assess the impact of probiotics as adjunct treatment for children with newly diagnosed ITP.

Methods

This randomized controlled trial was conducted on 60 children with newly diagnosed ITP who were allocated into 2 groups, group I the control group (n = 30), receiving standard corticosteroid therapy (prednisone 2 mg/kg/day for 1 week), group II the probiotic group (n = 30), receiving standard corticosteroid therapy (prednisone 2 mg/kg/day for 1 week) plus probiotics (Bacillus clausii, 2 billion/5 ml daily for 2 weeks). Platelet counts, bleeding scores, and side effects were assessed over a 12-months follow-up period.

Results

The probiotic group showed significantly higher platelet counts at 6 and 12 months compared to the control group (p < 0.01). The probiotic group also demonstrated significantly greater improvement in bleeding scores at 1 month (p = 0.002). Complete response rates, early, initial, durable responses, and remission rates were numerically higher in the probiotic group but did not reach statistical significance. No significant differences in side effect profiles were observed between the two groups.

Conclusions

Probiotic supplementation as an adjuvant to standard corticosteroid therapy may improve long-term platelet recovery and bleeding scores in children with newly diagnosed ITP.

Trial registration

PACTR202311873054587.