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临床试验/NCT05122520
NCT05122520已完成不适用

A Questionnaire to Identify Predictive Symptoms and Risk Factors for Hydrogen and Methane Breath Testing Outcomes

The Functional Gut Clinic1 个研究点 分布在 1 个国家目标入组 1,040 人开始时间: 2021年2月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,040
试验地点
1
主要终点
Determine positive predictive symptoms for SIBO positive participants determined by HMBT

研究概览

简要总结

Lactulose HMBT and Glucose HMBT are simple non-invasive tests to assess whether imbalances in gut bacteria may be contributing to troublesome tummy symptoms. These imbalances in gut bacteria include small intestinal bacterial overgrowth (SIBO) and excessive methane production.

Recently there has been a lot of work to done by experts in the field, to ensure that performance and interpretation of these tests are standardised, to help improve the clinical utility of these investigations. Although there is a lot of information currently available demonstrating the risk factors and symptoms associated with these conditions, there is a lack of data demonstrating the factors that might lead to a positive test according to these new parameters. This study aims to collect data on symptoms and medical history, in patients referred for lactulose and glucose HMBT in order further improve the effectiveness of this test in the future.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Participant is referred for and able to complete a postal Lactulose or Glucose HMBT according to protocol with The Functional Gut Clinic
  • Participant has capacity to understand written English
  • Participant can communicate well with the Investigator and to comply with the requirements for the entire study.

排除标准

  • 未提供

结局指标

主要结局

Determine positive predictive symptoms for SIBO positive participants determined by HMBT

时间窗: At same time as breath test

Using the HMBTQ

次要结局

  • Determine the frequency of recognised and potential risk factors in SIBO positive participants(At the same time as the breath test)
  • Determine positive predictive symptoms for excessive methane positive participants determined by HMBT(At same time as the breath test)
  • Determine the frequency of recognised and potential risk factors in excessive methane positive participants(At the same time as the breath test)

研究者

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

Dr Anthony Hobson

Clinical Director

The Functional Gut Clinic

研究点 (1)

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