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临床试验/NCT05622721
NCT05622721进行中(未招募)不适用

Impact of Pet Contact on Antimicrobial-associated Dysbiosis and Clostridioides Difficile Infection

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年5月30日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
200
试验地点
1
主要终点
Colonization or infection with C. difficile following antibiotic prophylaxis

研究概览

简要总结

Antimicrobial therapy can lead to disruption of the gut microbiome and infection with Clostridioides difficile, a disease associated with high morbidity and mortality, particularly among the elderly. Drawing on observations that pet ownership and close contact with pets are protective against colonization with C. difficile and recurrence of C. difficile infection, the proposed study will test the hypothesis that microbiota that provide colonization resistance against C. difficile are shared between patients and their pets and that pet contact can mitigate antimicrobial-associated gut dysbiosis and the risk of C. difficile infection. This study will further define epidemiologic and pathophysiologic characteristics of C. difficile infection and gut microbiome dysbiosis that could enhance therapeutic options for these conditions, potentially through non-invasive interventions involving animal contact.

详细描述

Clostridioides difficile infection (CDI) is one of the most common causes of healthcare-associated infectious diarrhea and results in significant morbidity and mortality. CDI occurs when the native gut microbiome is disrupted, most often following antimicrobial therapy, and the consequent dysbiosis results in a decrease in microbial diversity, changes in abundance of certain bacterial taxa, and loss of colonization resistance against C. difficile. Restoration of a "functionally intact" gut microbiome is critical to clearing C. difficile, and inadequate restoration can lead to recurrent CDI. The recovery of the gut microbiome from dysbiosis is poorly understood, and factors associated with having and re-gaining a providing colonization resistance against C. difficile are not well known. While animal reservoirs can serve as potential sources of pathogenic bacteria, studies by the candidate and other investigators found that pet ownership protects against colonization and re-infection with C. difficile. Moreover, microbiota are shared between pets and their owners, and the microbiomes of pets contain bacterial taxa that provide colonization resistance against C. difficile. Based on these data, the proposed research will 1) test the hypothesis that the observed protective effects of pet ownership are due to sharing of microbiota that provide colonization resistance against C. difficile between pets and owners; 2) determine whether pet contact mitigates antimicrobial-associated disruption of the gut microbiome and enhances its recovery; and 3) assess whether pet contact decreases the likelihood of colonization and infection with C. difficile following antimicrobial therapy. This will be accomplished though longitudinal sampling of the gut microbiome within the patient/pet unit among patients receiving prophylactic antimicrobials for non-enteric indications (dental implants).

The study will further define epidemiologic and pathophysiologic characteristics of CDI that could enhance therapeutic options for this disease. The underlying premise that animals are a source of protective microbiota rather than a reservoir of C. difficile represents a paradigm shift in CDI epidemiology that may identify animal contact as a novel microbiome-based form of therapy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •18 years of age or older.
  • •Receiving a dental implant.
  • •Ability to understand study procedures and to comply with them for the entire length of the study.

排除标准

  • •Antimicrobial therapy or hospitalization in the prior three months;
  • •Any gastrointestinal illness or underlying pathology (e.g., Inflammatory Bowel Disease, gastric ulceration)
  • •Sustained diarrheal disease (i.e., at least 3 episodes of loose or watery stool per day for 3 or more days) in the prior 3 months;
  • •Prior history of CDI in the prior year;
  • •Immunomodulating medication (e.g., tumor necrosis factor inhibitors or systemic steroids) or conditions (e.g., leukemia)
  • •Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

研究组 & 干预措施

Pet owner

Pet owners

Non pet owner

Non pet owners

结局指标

主要结局

Colonization or infection with C. difficile following antibiotic prophylaxis

时间窗: 3 days

The presence of C. difficile in patients' stool will be determined before and 3 days after the beginning of the antibiotic regimen

Longitudinal change in diversity and composition of the gut microbiota following oral antibiotic prophylaxis

时间窗: 90 days

Changes in alpha diversity, beta diversity and composition of the gut microbiome will be ascertained between baseline (prior to taking antibiotics) and 3, 10, 30 and 90 days following the start of the antibiotic regimen

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Laurel Redding

Assistant Professor

University of Pennsylvania

研究点 (1)

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