Niu Qianqian, Wang Wen, Liang Yan, Fang Shuguang, Wan Lin, Yang Guang
Department of Paediatrics, The Seventh Medical Centre of PLA General Hospital, Beijing, China.
Department of Paediatrics, The First Medical Centre, Chinese PLA General Hospital, Beijing, China.
Mol Nutr Food Res. 2025 Sep 2:e70234. doi: 10.1002/mnfr.70234.
Attention-deficit/hyperactivity disorder (ADHD) is a neuropsychiatric disorder. Emerging evidence suggests that gut microbiota may contribute to ADHD pathogenesis and that microbiota modulation could improve its symptoms. This study evaluated the safety and efficacy of a probiotic mixture containing Bifidobacterium animalis subsp. lactis BLa80 and Lacticaseibacillus rhamnosus LRa05 in children with ADHD. An open-label, single-arm trial enrolled children with ADHD (n = 42) who received daily oral probiotics (5 × 10 CFU) for 8 weeks. BRIEF-II and SNAP-IV scales were administered at baseline, Week 5, and Week 9 to assess changes in symptoms. Probiotic intervention significantly reduced scores in BRIEF-II domains (Global Executive Composite, Behavior Regulation Index, Emotion Regulation Index, and Cognitive Regulation Index) and SNAP-IV subscales (Inattention, Hyperactivity-Impulsivity) at Week 9 (all p < 0.05). One participant experienced mild diarrhea (grade 1, resolved spontaneously). No significant changes in hematological/biochemical parameters were observed. This exploratory study found that the probiotic mixture is safe and may improve ADHD symptoms in children, warranting further controlled trials to validate its efficacy and explore the underlying mechanisms. This study has been registered in a clinical trial registry. Trial Registration: ClinicalTrials.gov identifier: NCT06348121.
注意力缺陷多动障碍（ADHD）是一种神经精神疾病。新出现的证据表明，肠道微生物群可能与ADHD的发病机制有关，微生物群调节可能改善其症状。本研究评估了一种含有动物双歧杆菌亚种乳酸双歧杆菌BLa80和鼠李糖乳杆菌LRa05的益生菌混合物对ADHD儿童的安全性和有效性。一项开放标签、单臂试验纳入了ADHD儿童（n = 42），他们每天口服益生菌（5×10 CFU），持续8周。在基线、第5周和第9周使用BRIEF-II和SNAP-IV量表评估症状变化。在第9周时，益生菌干预显著降低了BRIEF-II领域（总体执行综合、行为调节指数、情绪调节指数和认知调节指数）和SNAP-IV子量表（注意力不集中、多动-冲动）的得分（所有p < 0.05）。一名参与者出现轻度腹泻（1级，自行缓解）。未观察到血液学/生化参数的显著变化。这项探索性研究发现，益生菌混合物是安全的，可能改善儿童的ADHD症状，需要进一步的对照试验来验证其疗效并探索潜在机制。本研究已在临床试验注册中心注册。试验注册：ClinicalTrials.gov标识符：NCT06348121。
