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临床试验/NCT04684849
NCT04684849招募中不适用

Assessment and Validation of Electronic Gas and Bloating Diary

Augusta University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Correlation of electronic APP diary information with paper form gas and bloating diary in healthy subjects

研究概览

简要总结

The investigator's goal is to improve the patient's compliance and accurate capture of patient reported gas and bloating symptoms, by utilizing a phone application that interactively records each gas and bloating event in addition to bowel events and other bowel symptoms. Such an electronic stool diary may relieve the burden of using a paper daily stool diary. The investigator will compare and validate the electronic gas and bloating diary with the paper gas and bloating diary.

详细描述

Gas-related symptoms (GRS) such as abdominal bloating, flatulence, and belching are some of the most common gastrointestinal complaints posed by the general population. These are hallmark symptoms in patients with functional gut disorders like irritable bowel syndrome but have also been linked to conditions such as gut hypersensitivity, altered gut microbiota and altered gut motility. The main issue with grasping the full impact of these symptoms on a patients' quality of life is that they are largely subjective and thus almost impossible to standardize. However, given their pervasiveness there is merit attempting to gauge their severity in as objective a manner as possible in order to track disease progress and response to treatment. GRS can be widely irregular and requiring patients to call into the office to answer questionnaires post treatment or keep handwritten logs to turn in later can lead to inaccurate data collection that can hinder accurate diagnosis and management. The ubiquitous nature of smartphones and user-friendly interfaces of electronic applications allow for information to be logged/accessed remotely and securely, each log would have their own time stamp and be recorded in an organized, consistent manner.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Correlation of electronic APP diary information with paper form gas and bloating diary in healthy subjects

时间窗: 2 weeks each

The gas and bloating parameters recorded in the paper form gas bloating diary over 2 weeks will be correlated with the electronic APP gas and bloating diary parameters using Pearson correlation in healthy subjects

Correlation of electronic APP diary information with paper form gas and bloating diary in gas and bloating subjects

时间窗: 2 weeks each

The gas and bloating parameters recorded in the paper form gas and bloating diary over 2 weeks will be correlated with the electronic APP gas and bloating diary parameters using Pearson correlation in gas and bloating subjects

次要结局

  • Abdominal distension(2 weeks each)
  • Indigestion(2 weeks)
  • Vomiting(2 weeks)
  • Abdominal Pain(2 weeks each)
  • Belching(2 weeks each)
  • Nausea(2 weeks)
  • Constipation(2 weeks)
  • Flatulence (Gas)(2 weeks each)
  • Bloating(2 weeks each)
  • Diarrhea(2 weeks)
  • Number of Bowel Movements(2 weeks)

研究者

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

Satish Rao

Professor of Medicine

Augusta University

研究点 (1)

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