Assessment and Validation of Electronic Gas and Bloating Diary

Augusta University

Status: Enrolling

Conditions: Bloating; Diarrhea; Constipation; Distension; Gas

Treatments: Other: Paper Diary; Other: APP Diary

Study type: Observational

Funder types: Other

Identifiers

NCT04684849

1541299

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion/Exclusion for gas and bloating subjects:

Inclusion:

1. Anyone 18 to 80 years of age, inclusive with gas-related symptoms (GRS) such as gas and bloating, plus any of the following: distension, diarrhea, and/ or abdominal discomfort.
2. Normal upper endoscopy, normal colonoscopy (<5 years) if patient is > 50 years of age, normal computerized abdominal tomography scan, or a normal right upper quadrant scan

Exclusion:

1. Women of childbearing age will be asked if they are pregnant, and a negative response will be sufficient. No pregnancy test will be performed.
2. History of previous GI surgeries (except for cholecystectomy, hysterectomy, and appendectomy)
3. Significant co-morbid medical conditions, including stroke, COPD( Chronic Obstructive Pulmonary Disease) and cancers (except for non-melanotic skin cancer)
4. Recent hospitalization within 30 days of enrollment in this study
5. Recent History (within 4 weeks) of antibiotic use
6. Recent History (within one week) of a colonoscopy or barium study

Inclusion/Exclusion for healthy subjects:

Inclusion:

1. Anyone 18 to 80 years of age, inclusive with no medical problems and a negative bowel disease screening questionnaire.

Trial design

40 participants in 2 patient groups

Healthy subjects

Description:

Subjects who are healthy without disease

Treatment:

Other: APP Diary

Other: Paper Diary

Gas and Bloating patients

Description:

Patients with symptoms of gas and bloating

Treatment:

Other: APP Diary

Other: Paper Diary