Assessment and Validation of Electronic Gas and Bloating Diary

Recruiting

• Conditions: Gas; Constipation; Bloating; Diarrhea; Distension
• Interventions: Other: APP Diary; Other: Paper Diary

• Registration Number: NCT04684849
• Lead Sponsor: Augusta University

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.

Study Timeline

• Study Start: 2020-09-10
• Study First Submitted: 2020-11-19
• Study First Submitted QC: 2020-12-21
• Study First Posted: 2020-12-28
• Status Verified: 2022-07
• Last Update Submitted: 2022-10-21
• Last Update Posted: 2022-10-24
• Primary Completion: 2023-12-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy subjects	APP Diary	Subjects who are healthy without disease
Gas and Bloating patients	Paper Diary	Patients with symptoms of gas and bloating
Healthy subjects	Paper Diary	Subjects who are healthy without disease
Gas and Bloating patients	APP Diary	Patients with symptoms of gas and bloating

Primary Outcome Measures

Name	Time	Method
Correlation of electronic APP diary information with paper form gas and bloating diary in healthy subjects	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	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 Outcome Measures

Name	Time	Method
Abdominal distension	2 weeks each	Frequency, duration, and severity of abdominal distension will be compared between the APP and gas and bloating diary and between healthy subjects and patients with gas and bloating .
Indigestion	2 weeks	Frequency, duration, and severity of indigestion will be compared between the APP and gas and bloating diary and between healthy subjects and patients with gas and bloating.
Vomiting	2 weeks	Frequency and severity of vomiting will be compared between the APP and gas and bloating diary and between healthy subjects and patients with gas and bloating.
Abdominal Pain	2 weeks each	Frequency, duration, and severity of abdominal pain will be compared between the APP and gas and bloating diary and between healthy subjects and patients with gas and bloating.
Belching	2 weeks each	Frequency, duration, and severity of belching will be compared between the APP and gas and bloating diary and between healthy subjects and patients with gas and bloating.
Nausea	2 weeks	Frequency, duration, and severity of nausea will be compared between the APP and gas and bloating diary and between healthy subjects and patients with gas and bloating.
Constipation	2 weeks	Frequency, duration, and severity of constipation will be compared between the APP and gas and bloating diary and between healthy subjects and patients with gas and bloating.
Flatulence (Gas)	2 weeks each	Frequency, duration, and severity of flatulence will be compared between the APP and gas and bloating diary and between healthy subjects and patients with gas and bloating .
Bloating	2 weeks each	Frequency, duration, and severity of bloating will be compared between the APP and gas and bloating diary and between healthy subjects and patients with gas and bloating .
Diarrhea	2 weeks	Frequency and severity of diarrhea will be compared between the APP and gas and bloating diary and between healthy subjects and patients with gas and bloating.
Number of Bowel Movements	2 weeks	The number of Bowel Movements will be compared between the APP and gas and bloating diary and between healthy subjects and patients with gas and bloating.

Trial Locations

Locations (1)

Augusta University; 🇺🇸 Augusta, Georgia, United States