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临床试验/NCT06285734
NCT06285734招募中不适用

Clinical Characteristics of Small Intestinal Bacterial Overgrowth in Individuals with Abdominal Distention

Shandong University1 个研究点 分布在 1 个国家目标入组 402 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
402
试验地点
1
主要终点
Positive rate of SIBO in patients with abdominal distension

研究概览

简要总结

Abdominal distention represents a prevalent clinical manifestation characterized by an unclear etiology and pathogenesis. This symptomatology is frequently observed in various conditions, including small intestinal bacterial overgrowth (SIBO) and abnormal orocecal transit time (OCTT). The utilization of the breath test as a non-invasive diagnostic approach has become widespread in recent years for identifying SIBO and abnormalities in OCTT. In this study, the prevalence of SIBO and OCTT irregularities in individuals presenting with abdominal distention was ascertained through the implementation of the breath test. Furthermore, the correlation between abdominal distention and SIBO/OCTT was analysed to enhance the elucidation of the underlying etiology of abdominal distention. These findings aim to offer valuable insights for refining clinical comprehension and strategies related to the diagnosis and treatment of abdominal distention.

详细描述

Abdominal distention represents a prevalent clinical manifestation characterized by an unclear etiology and pathogenesis. And the prevalence of abdominal distension is high in the population. This symptomatology is frequently observed in various conditions, including small intestinal bacterial overgrowth (SIBO) and abnormal orocecal transit time (OCTT). The utilization of the breath test as a non-invasive diagnostic approach has become widespread in recent years for identifying SIBO and abnormalities in OCTT. In this study, the prevalence of SIBO and OCTT irregularities in individuals presenting with abdominal distention was ascertained through the implementation of the breath test. Furthermore, the correlation between the clinical features such as severity, location, and frequency of abdominal distension and SIBO/OCTT was analysed to enhance the elucidation of the underlying etiology of abdominal distention. These findings aim to offer valuable insights for refining clinical comprehension and strategies related to the diagnosis and treatment of abdominal distention.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18 to 70 years.
  • Patients presenting with the primary complaint of abdominal bloating and/or abdominal distension, or those exhibiting abdominal distension with prominence over other symptoms.

排除标准

  • Patients who are pregnant or lactating.
  • Patients have history of gastrointestinal malignancy or gastrointestinal surgery.
  • Patients manifesting food intolerance or presenting with a confirmed diagnosis or suspicion of lactose intolerance.
  • Patients with urinary system (chronic kidney disease, etc.), immune system (scleroderma, etc.), nervous system (Parkinson's disease, etc.), mental system (depression, etc.), or other diseases outside the digestive system.
  • Patients who used antibiotics or microecological agents or underwent endoscopic examination within two weeks.
  • Patients with a medication history encompassing motility enhancers, secretory enhancers, antifoaming agents, spasmolytics, opioids, and antidepressants within the past week.
  • Patients who are unwilling or incapable to provide informed consents.

结局指标

主要结局

Positive rate of SIBO in patients with abdominal distension

时间窗: 2024-03-01 to 2025-08-01

Detect the positive rate of SIBO in patients with abdominal distension by breath test

次要结局

  • Positive rate of abnormal OCTT in patients with abdominal distension(2024-03-01 to 2025-08-01)
  • Correlation between clinical features of patients with abdominal distension and SIBO(2024-03-01 to 2025-08-01)
  • Correlation between clinical features of patients with abdominal distension and OCTT(2024-03-01 to 2025-08-01)

研究者

发起方
Shandong University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiuli Zuo

Professor, Director of gastroenterology department of Qilu hospital

Shandong University

研究点 (1)

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