NCT04684849

Assessment and Validation of Electronic Gas and Bloating Diary

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Augusta University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gas
• Bloating
• Distension
• Constipation
• Diarrhea

Interventions

Type	Name	Description
OTHER	APP Diary	Subjects keep a multi- item electronic digital App survey of symptoms for 2 weeks
OTHER	Paper Diary	Subjects keep a multi-item paper survey of symptoms for 2 weeks

Timeline

• Start date: 2020-09-10
• Primary completion: 2023-12-31
• Completion: 2024-08-31
• First posted: 2020-12-28
• Last updated: 2022-10-24

Locations

1 site across 1 country: United States