Assessment and Validation of Electronic Gas and Bloating Diary
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gas
- Sponsor
- Augusta University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Correlation of electronic APP diary information with paper form gas and bloating diary in healthy subjects
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Satish Rao
Professor of Medicine
Augusta University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Correlation of electronic APP diary information with paper form gas and bloating diary in healthy subjects
Time Frame: 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
Time Frame: 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
Secondary Outcomes
- 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)