In-vitro and preclinical testing of bacillus subtilis UBBS-14 probiotic in rats shows no toxicity.

IF 2.2 4区 医学 Q3 TOXICOLOGY Toxicology Research Pub Date : 2024-02-22 eCollection Date: 2024-02-01 DOI:10.1093/toxres/tfae021
Ankit Negi, Tulasi Pasam, Syed Muhammad Farqadain, Y Mahalaxmi, Manoj P Dandekar
{"title":"In-vitro and preclinical testing of <i>bacillus subtilis</i> UBBS-14 probiotic in rats shows no toxicity.","authors":"Ankit Negi, Tulasi Pasam, Syed Muhammad Farqadain, Y Mahalaxmi, Manoj P Dandekar","doi":"10.1093/toxres/tfae021","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Probiotics made from <i>Bacillus subtilis</i> provide a wide spread of health benefits, particularly in the treatment of diarrhea and gastrointestinal problems. Herein, we employed in vitro and in vivo paradigms to assess the potential adverse effects and toxicity of <i>B. subtilis</i> UBBS-14.</p><p><strong>Materials and methods: </strong>According to Organization for Economic Co-operation and Development (OECD) 423 and 407 requirements, a preclinical investigation was conducted in male and female Sprague-Dawley rats. Acute toxicity was examined following a single peroral (PO) administration of 5,000 mg/kg body weight (bw) i.e. equivalent to 500 billion colony-forming units (CFU) per kg bw. Single administration of <i>B. subtilis</i> UBBS-14 showed no mortality or adverse effects until the 14-day observation period, indicating LD50 is >5,000 mg/kg bw.</p><p><strong>Results: </strong>Incubation of <i>B. subtilis</i> UBBS-14 with Caco2, HT29, and Raw 264.7 cell lines, showed no cytotoxic effects. This probiotic strain was also found responsive to the majority of antibiotics. For a 28-day repeated dose toxicity study, rats were administered 100, 500, and 1,000 mg/kg bw daily once (10, 50, and 100 billion CFU/kg bw/day, respectively) doses of <i>B. subtilis</i> UBBS-14. No notable changes were seen in the morphology, weight, and histopathology of the critical internal organs. The haematological, biochemical, electrolyte (sodium, potassium, chloride, and calcium), and urine analytical results were within the normal range and equivalent to the vehicle-treated group.</p><p><strong>Conclusion: </strong><i>B. subtilis</i> UBBS-14's no-observed-effect level (NOEL) was thus determined to be >1,000 mg/kg bw/day following a 28-day oral dosing.</p>","PeriodicalId":105,"journal":{"name":"Toxicology Research","volume":null,"pages":null},"PeriodicalIF":2.2000,"publicationDate":"2024-02-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10891425/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Toxicology Research","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/toxres/tfae021","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/2/1 0:00:00","PubModel":"eCollection","JCR":"Q3","JCRName":"TOXICOLOGY","Score":null,"Total":0}
引用次数: 0

Abstract

Introduction: Probiotics made from Bacillus subtilis provide a wide spread of health benefits, particularly in the treatment of diarrhea and gastrointestinal problems. Herein, we employed in vitro and in vivo paradigms to assess the potential adverse effects and toxicity of B. subtilis UBBS-14.

Materials and methods: According to Organization for Economic Co-operation and Development (OECD) 423 and 407 requirements, a preclinical investigation was conducted in male and female Sprague-Dawley rats. Acute toxicity was examined following a single peroral (PO) administration of 5,000 mg/kg body weight (bw) i.e. equivalent to 500 billion colony-forming units (CFU) per kg bw. Single administration of B. subtilis UBBS-14 showed no mortality or adverse effects until the 14-day observation period, indicating LD50 is >5,000 mg/kg bw.

Results: Incubation of B. subtilis UBBS-14 with Caco2, HT29, and Raw 264.7 cell lines, showed no cytotoxic effects. This probiotic strain was also found responsive to the majority of antibiotics. For a 28-day repeated dose toxicity study, rats were administered 100, 500, and 1,000 mg/kg bw daily once (10, 50, and 100 billion CFU/kg bw/day, respectively) doses of B. subtilis UBBS-14. No notable changes were seen in the morphology, weight, and histopathology of the critical internal organs. The haematological, biochemical, electrolyte (sodium, potassium, chloride, and calcium), and urine analytical results were within the normal range and equivalent to the vehicle-treated group.

Conclusion: B. subtilis UBBS-14's no-observed-effect level (NOEL) was thus determined to be >1,000 mg/kg bw/day following a 28-day oral dosing.

查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
在大鼠体内对枯草杆菌 UBBS-14 益生菌进行的体外和临床前测试表明,它没有毒性。
导言:由枯草芽孢杆菌制成的益生菌具有广泛的健康益处,尤其是在治疗腹泻和胃肠道问题方面。在此,我们采用体外和体内范例来评估枯草芽孢杆菌 UBBS-14 的潜在不良影响和毒性:根据经济合作与发展组织(OECD)423 和 407 的要求,我们对雄性和雌性 Sprague-Dawley 大鼠进行了临床前调查。单次口服给药 5,000 毫克/千克体重(即相当于每千克体重 5,000 亿个菌落形成单位(CFU))后,对急性毒性进行了检测。单次服用枯草芽孢杆菌 UBBS-14 在 14 天的观察期内没有出现死亡或不良反应,表明半数致死剂量大于 5,000 毫克/千克体重:结果:将枯草杆菌 UBBS-14 与 Caco2、HT29 和 Raw 264.7 细胞系培养,未发现细胞毒性作用。这种益生菌株对大多数抗生素也有反应。在一项为期 28 天的重复剂量毒性研究中,大鼠每天一次分别服用 100、500 和 1,000 毫克/千克体重的枯草杆菌 UBBS-14(分别为 100、500 和 1,000 亿 CFU/千克体重/天)。重要内脏器官的形态、重量和组织病理学未见明显变化。血液学、生物化学、电解质(钠、钾、氯化物和钙)和尿液分析结果均在正常范围内,与车辆处理组相当:结论:因此,在口服 28 天后,枯草芽孢杆菌 UBBS-14 的无观测效应水平(NOEL)被确定为大于 1,000 毫克/千克体重/天。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 去求助
来源期刊
Toxicology Research
Toxicology Research TOXICOLOGY-
CiteScore
3.60
自引率
0.00%
发文量
82
期刊介绍: A multi-disciplinary journal covering the best research in both fundamental and applied aspects of toxicology
期刊最新文献
Design and computational analysis of a novel Azurin-BR2 chimeric protein against breast cancer. Synergistic effect of curcumin and Piperine loaded Niosomal nanoparticles on acute pulmonary toxicity induced by Paraquat in mice. Upregulation of ACSL, ND75, Vha26 and sesB genes by antiepileptic drugs resulted in genotoxicity in drosophila. Potential protective role of chlorogenic acid against cyclophosphamide-induced reproductive damage in male mice. The cliff-edge of toxicological concern: highlighting the potential issues of an over-reliance on "less-than-lifetime" thresholds.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1