跳至主要内容
临床试验/NCT06845527
NCT06845527招募中不适用

Characteristics and Outcomes of Outpatients Referred to an Gut Microbiota Clinic

Fondazione Policlinico Universitario Agostino Gemelli IRCCS2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年3月13日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
2
主要终点
Microbiological Characteristics of Patients at the Gut Microbiota Clinic

研究概览

简要总结

The gut microbiota plays a crucial role in human health, influencing metabolism, immunity, and pathogen resistance. Research has linked microbiome dysbiosis to various intestinal and extra-intestinal disorders, prompting interest in therapeutic strategies like fecal microbiota transplantation (FMT), which is now standard for recurrent Clostridioides difficile infection and shows promise for other conditions.

Despite its potential, the clinical integration of microbiome research remains limited due to biological complexity, lack of clinician awareness, and the absence of standardized guidelines. Meanwhile, patient demand for microbiome-based interventions is rising, leading some to seek non-scientific alternatives with potential health risks.

Since 2016, the Gut Microbiota Clinic at Fondazione Policlinico Gemelli has provided personalized microbiota-based treatments, collaborating with specialists across disciplines. The clinic primarily serves patients with gastrointestinal and extra-intestinal disorders and employs a multidisciplinary approach.

This study aims to characterize the clinical and microbiological and cytokine profiles of patients attending the clinic and establish a microbiological database. Primary and secondary endpoints include microbiota composition changes and clinical outcomes assessed through validated diagnostic tools.

详细描述

The gut microbiota is a key mediator of various human functions, including metabolism, the immune system, and resistance to pathogen colonization. A growing body of scientific research has demonstrated-initially through association studies and subsequently through mechanistic experiments-that gut microbiome dysbiosis is linked to a wide range of both intestinal and extra-intestinal disorders.

Recent evidence indicates that the gut microbiota is part of a complex network of interactions involving other host microbial communities and the immune system. In particular, the oral-gut axis has emerged as a key pathway through which the oral microbiota may influence gut microbial composition and function. Furthermore, host-microbiota interactions are mediated by immune mechanisms, including cytokine production and systemic inflammatory responses, linking microbiota composition to disease pathophysiology and clinical outcomes.

This body of evidence has led to the exploration of gut microbiome modulation as a therapeutic strategy, such as fecal microbiota transplantation (FMT), which has become a standard treatment for recurrent Clostridioides difficile infection and has also shown promise for several other indications, including ulcerative colitis, irritable bowel syndrome, and metabolic syndrome.

Furthermore, there is increasing interest in leveraging the gut microbiome as a diagnostic tool in clinical practice for various applications, including disease diagnosis, prognosis, and risk assessment; prediction of patient response to specific therapies; guidance and personalization of microbiome-targeted interventions such as probiotics or FMT; and monitoring the effectiveness of these treatments.

Despite this enthusiasm, however, the integration of microbiome research advancements into routine clinical practice remains generally limited. This gap can be attributed to several factors, primarily the complexity of microbiome biology, the limited knowledge of gut microbiota among most healthcare professionals, and the absence of established guidelines and infrastructures for the clinical application of microbiome research.

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

入选标准

  • Age ≥18 years.
  • Patients attending the Microbiota Outpatient Clinic at Fondazione Policlinico Universitario "A. Gemelli" IRCCS.
  • Ability to understand the study procedures and provide written informed consent.
  • Patients for whom gut microbiota testing has been requested as part of routine clinical care.

排除标准

  • Age <18 years.
  • Severe psychiatric disorders that may interfere with study participation or informed consent.
  • Inability to provide written informed consent.

结局指标

主要结局

Microbiological Characteristics of Patients at the Gut Microbiota Clinic

时间窗: 24 months

The microbiome test results that patients will bring to the visit will be analyzed, including: Alpha and beta diversity Taxonomic Composition (proportion of different bacterial phyla, genera, and species)

次要结局

  • Changes in Microbiota Composition in Patients Undergoing Routine Clinical Microbiota Testing After Standard Treatments(24 months)
  • Assessment of CDAI Scores(24 months)
  • Assessment of IBS-SSS(24 months)
  • Pain intensity(24 months)
  • Assessment of PFS Scores(24 months)
  • Assessment of OS scores(24 months)
  • Changes in Microbiota Composition in Patients Undergoing Routine Clinical Microbiota Testing After Standard Treatments(24 months)
  • Assessment of CDAI Scores(24 months)
  • Assessment of IBS-SSS(24 months)
  • Assessment of PFS Scores(24 months)
  • Pain intensity(24 months)

研究者

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

IANIRO GIANLUCA

Principal Investigator, MD, PhD

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (2)

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