Division of Gastroenterology, Department of Pediatrics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
Division of Gastroenterology, Department of Pediatrics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand. Correspondence to: Dr Pornthep Tanpowpong, Division of Gastroenterology, Department of Pediatrics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
Indian Pediatr. 2023 Jun 15;60(6):453-458. Epub 2023 Feb 9.
To evaluate the efficacy of Bacillus clausii in the treatment of pediatric constipation.
A randomized, double-blind, placebo-controlled trial was conducted from January, 2021 to January, 2022 in children aged 1-5 years diagnosed with functional constipation according to Rome IV criteria. They were assigned to receive either B. clausii or placebo, once daily for four weeks. The primary out-come was treatment success (defined as ≥3 spontaneous stools per week and stool consistency grade ≥3 on Bristol stool chart). The secondary outcome was a comparison of stool frequency, consistency (defined by Bristol stool grade), and constipation-related symptoms.
This trial enrolled 38 children (B. clausii, n=20 and placebo, n=18). At 4 weeks, no significant difference was noted in the treatment success between B. clausii and placebo groups [45% vs 56%; P=0.52). On within-group analyses, the mean (SD) of Bristol stool grade increased in both the B. clausii [1.7 (0.5) to 2.8 (1.2); P=0.003] and placebo [1.8 (0.5) to 2.8 (1.2); P=0.01] groups. Significant increases in the treatment success rate (22% to 56%, P=0.01) and mean stool frequency per week [3 (0.9) to 4.2 (1.7), P=0.01] were pronounced only in the placebo group. The frequency of painful defecation and large fecal mass were also significantly decreased in both the groups. No serious adverse events were observed.
A 4-week course of B. clausii as the sole treatment was not more effective than a placebo for the management of functional constipation in children aged 1-5 years.
评估枯草芽孢杆菌治疗小儿便秘的疗效。
这是一项在 2021 年 1 月至 2022 年 1 月期间开展的、针对符合 Rome IV 标准的功能性便秘患儿的随机、双盲、安慰剂对照试验。这些患儿被随机分为枯草芽孢杆菌组或安慰剂组，每天一次，疗程 4 周。主要结局为治疗成功（定义为每周至少 3 次自主排便且布里斯托大便图表粪便性状分级≥3）。次要结局为比较两组患儿的排便频率、粪便性状（根据布里斯托粪便分级定义）和便秘相关症状。
本试验共纳入 38 例患儿（枯草芽孢杆菌组 20 例，安慰剂组 18 例）。4 周时，枯草芽孢杆菌组和安慰剂组的治疗成功率（45% vs 56%；P=0.52）无显著差异。在组内分析中，枯草芽孢杆菌组[1.7（0.5）至 2.8（1.2）；P=0.003]和安慰剂组[1.8（0.5）至 2.8（1.2）；P=0.01]的布里斯托粪便分级均值（标准差）均增加。仅在安慰剂组中，治疗成功率（22%至 56%，P=0.01）和每周平均排便次数[3（0.9）至 4.2（1.7），P=0.01]显著增加。两组患儿的排便疼痛和大便干结感也均显著减轻。两组均未观察到严重不良事件。
4 周疗程的枯草芽孢杆菌单一疗法并不优于安慰剂，对 1-5 岁儿童功能性便秘的治疗效果不佳。
