1 Centre for Research & Development, Unique Biotech Ltd., Plot No. 2, Phase-II, Alexandria Knowledge Park, Hyderabad, Telangana 500078, India.
2 MV Hospital and Research Centre, Department of Pediatrics, Room No 01 314/30, Mirza Mandi Chowk, Lucknow, Uttar Pradesh, India.
Benef Microbes. 2019 Mar 13;10(2):149-154. doi: 10.3920/BM2018.0094. Epub 2019 Jan 14.
Acute diarrhoea is one of the leading causes of mortality in infants and young children. Evidence suggests that probiotics can reduce diarrhoea duration. As the effects of probiotics are strain specific, the effect of Bacillus clausii UBBC-07, a safe probiotic strain in the treatment of acute diarrhoea in children was studied. The double blind, randomised, placebo-controlled, parallel group multicentric study was conducted at two outpatient facility sites in Lucknow, India. Children aged six months to five years suffering from acute diarrhoea, were randomly assigned to receive either probiotic (B. clausii UBBC-07) spore suspension or placebo suspension twice daily apart from oral rehydration solution (ORS). The duration of treatment was for five days with a follow -up until the 10 day. Outcomes evaluated were duration and frequency of diarrhoea, consistency of stool, fever and vomiting. The duration of diarrhoea was significantly shorter (P<0.05) in patients who received B. clausii suspension (75.66±13.23 h) than in placebo treated group (81.6±15.43 h). The average daily number of stools (frequency) was 8.67±3.42 at baseline in treatment group receiving B. clausii and 8.53±3.19 in placebo group. By day 4, there was a significant reduction (P<0.01) in frequency of stools in probiotic treated group (3.46±0.66) as compared to placebo group (4.57±1.59). Improvement in stool consistency was also observed in the probiotic treated group as compared to the placebo group. There was no effect on vomiting and duration of fever. B. clausii UBBC-07 significantly decreased the duration and frequency of diarrhoea as compared to placebo indicating effectiveness of strain in the treatment of acute diarrhoea in children and could be a safe alternative to antibiotics.
急性腹泻是导致婴幼儿死亡的主要原因之一。有证据表明，益生菌可以减少腹泻持续时间。由于益生菌的效果因菌株而异，因此研究了一种安全的益生菌菌株芽孢杆菌 UBBC-07 在治疗儿童急性腹泻中的作用。这项双盲、随机、安慰剂对照、平行分组的多中心研究在印度勒克瑙的两个门诊机构进行。年龄在 6 个月至 5 岁之间患有急性腹泻的儿童被随机分配接受益生菌（芽孢杆菌 UBBC-07）孢子悬浮液或安慰剂悬浮液，每天两次，除了口服补液盐（ORS）。治疗持续 5 天，随访至第 10 天。评估的结果是腹泻的持续时间和频率、粪便的稠度、发热和呕吐。接受芽孢杆菌悬浮液治疗的患者腹泻持续时间明显缩短（P<0.05）（75.66±13.23 h）比安慰剂治疗组（81.6±15.43 h）。治疗组接受芽孢杆菌治疗的患者在基线时每日平均排便次数（频率）为 8.67±3.42，安慰剂组为 8.53±3.19。到第 4 天，益生菌治疗组的粪便频率明显减少（P<0.01）（3.46±0.66）与安慰剂组（4.57±1.59）相比。益生菌治疗组的粪便稠度也有所改善与安慰剂组相比。呕吐和发热持续时间没有影响。与安慰剂相比，芽孢杆菌 UBBC-07 显著降低了腹泻的持续时间和频率，表明该菌株在治疗儿童急性腹泻方面的有效性，并且可以作为抗生素的安全替代物。
