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临床试验/NCT06285734
NCT06285734已完成不适用

Clinical Characteristics of Small Intestinal Bacterial Overgrowth in Individuals With Abdominal Bloating/Distention

Shandong University2 个研究点 分布在 1 个国家目标入组 387 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
已完成
发起方
入组人数
387
试验地点
2
主要终点
Positive rate of SIBO in patients with abdominal distension

研究概览

简要总结

Abdominal bloating/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). The utilization of the breath test as a non-invasive diagnostic approach has become widespread in recent years for identifying SIBO. In this study, the prevalence of SIBO irregularities in individuals presenting with abdominal bloating/distention was ascertained through the implementation of the breath test. Furthermore, the correlation between abdominal bloating/distention and SIBO was analysed to enhance the elucidation of the underlying etiology of abdominal bloating/distention. These findings aim to offer valuable insights for refining clinical comprehension and strategies related to the diagnosis and treatment of abdominal bloating/distention.

详细描述

Abdominal bloating/distention represents a prevalent clinical manifestation characterized by an unclear etiology and pathogenesis. And the prevalence of Abdominal bloating/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). The utilization of the breath test as a non-invasive diagnostic approach has become widespread in recent years for identifying SIBO. In this study, the prevalence of SIBO irregularities in individuals presenting with abdominal bloating/distention was ascertained through the implementation of the breath test. Furthermore, the correlation between abdominal bloating/distention and SIBO was analysed to enhance the elucidation of the underlying etiology of abdominal bloating/distention. These findings aim to offer valuable insights for refining clinical comprehension and strategies related to the diagnosis and treatment of abdominal bloating/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 70 Years(Adult, Older 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

Positive rate of SIBO in patients with abdominal bloating/distension

时间窗: 2024-03-01 to 2026-06-01

Detect the positive rate of SIBO in patients with abdominal bloating/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)
  • Correlation between clinical features of patients with abdominal bloating/distension and SIBO(2024-03-01 to 2026-06-01)

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 (2)

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