跳至主要内容
临床试验/NCT04786938
NCT04786938已完成4 期

Effect of Saccaromyces Boulardii CNCM I-745 Supplementation on the Fecal Resistome of Patients Treated Against Helicobacter Pylori Infection

Universidad San Francisco de Quito0 个研究点目标入组 72 人开始时间: 2016年4月7日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
72
主要终点
Modifications in the fecal resistome during a probiotic administration

研究概览

简要总结

Eradication therapy against Helicobacter pylori (Hp) carries adverse effects, such as altering the intestinal microbiota's structure and function and selecting commensals and pathogens resistant to antibiotics. This last undesirable effect turns the microbiota into a reservoir of resistance genes. Saccharomyces boulardii CNCM I-745 (Sb) can improve dysbiosis and reduce the abundance of multi-resistant bacteria. The objective of the current project is to characterize the resistome of individuals treated with anti-H. pylori therapy in the presence or absence of Sb in fecal samples. Applying metagenomics and using next-generation sequencing tools, the investigators seek to demonstrate the beneficial effect of Sb on the gut microbiota by reducing the abundance of resistance genes and characterizing bacteria modulated by this probiotic-yeast. The investigators expect to find an increase in the diversity and relative abundance of antibiotic resistance genes (ARGs) in the intestine of participants who did not receive Sb during Hp eradication therapy and one month after completing treatment. The increase in ARGs is probably correlated with the presence of Clostridia and Bacteroides.

详细描述

Antibiotic use is one of the most common therapeutic strategies of modern medicine. Together with the significant beneficial effects of antibiotic use, side effects accompany the use of these drugs, including the increasing appearance of antibiotic-resistant microbes, a global public health problem. Other significant side effects include gastrointestinal-related symptoms such as diarrhea, pain, intestinal discomfort, and flatulence, which can be the consequence of dysbiosis. A common strategy to limit antibiotic-associated side effects is the addition of probiotics, as S. boulardii CNCM I-745 (Sb). The use of bacterial probiotics to reduce antibiotic-associated side effects has several potential limitations, including the destruction of probiotics, development of probiotics strains resistant to antibiotics, and passage of antibiotic-resistant genes to pathogenic bacteria through horizontal gene transfer. Sb is a probiotic yeast whose benefits on intestinal dysbiosis have been associated with establishing a favorable growth environment for the normal intestinal microbiota. Due to the yeast nature of this probiotic, the limitations of bacterial-probiotics cannot be accounted for during Sb use. Consequently, it is crucial to study the molecular mechanism elicited by Sb on intestinal microbiota, including changes in resistome.

In our previous study regarding the supplementation with Sb on the treatment against H. pylori (Hp) infection, patients that received the probiotic had a significantly lower frequency of gastrointestinal symptoms. Additionally, those patients have a higher number of bacterial diversity evenness (P=0.0156), higher abundance of Enterobactereacea, and lower abundance of Bacteroides and Clostridia upon treatment completion and one month later. Bacteroides and Clostridia have been previously implicated as antibiotic multi-resistant pro-inflammatory strains. The objective of the current project is to characterize the resistome of individuals treated with anti-H. pylori therapy in the presence or absence of Sb in fecal samples.

Specific aims To determine the resistome changes before and after Hp eradication treatment in patients that have received or not Sb.

To compare the resistome patterns between patients treated for Hp infection that have received or not SB, at the time of completion of treatment and one month after finishing them.

Based on the shotgun metagenomics, the researchers seek to characterize the microbiome and resistome in fecal samples and understand the microbiome's functional characteristics, including virulence genes, metabolic pathways, and mobile genetic elements.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with typical dyspepsia symptoms from whom an upper gastrointestinal endoscopy with biopsies was done for histopathological examination.

排除标准

  • Pregnancy or lactation.
  • Subjects diagnosed with another gastrointestinal disease such as inflammatory bowel disease and malabsorption syndromes.
  • Subjects taking or are planning to take pre- pro- or symbiotic.
  • Subjects that have received antibiotics in the last month for any reason.
  • Subjects who have received corticosteroids chronically for any reason; have received medication to inhibit nutrient absorption; use of NSAID during the last month that cannot stop the treatment.

研究组 & 干预措施

Saccharomyces boulardii

Experimental

Conventional treatment (amoxicillin 1 g three times a day, tinidazole 1g four times a day, and omeprazole 40mg twice a day; n=34) plus S. boulardii CNCM I-745 (approximately 22.5 x109 CFU

干预措施: Saccharomyces Boulardii-Containing Product in Oral Dose Form (Drug)

结局指标

主要结局

Modifications in the fecal resistome during a probiotic administration

时间窗: Participating patients were asked to provide three fecal samples during the study, the first before initiation of antibiotics, the second immediately after completion of antibiotics, and the last sample 1 month after finishing the treatment.

Changes in abundance and diversity of antimicrobial resistance genes in fecal micobiota from individuals treated against a H. pylori infection with Saccharomyces boulardii CNCM I-745 as an additional therapy to conventional treatment regimen.

次要结局

未报告次要终点

研究者

发起方
Universidad San Francisco de Quito
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paúl Cárdenas, PhD

Professor at the Institute of Microbiology

Universidad San Francisco de Quito

相似试验