Recruiting

Observational Study

Sponsor:

Augusta University

Code:

NCT04684849

Conditions

Gas

Bloating

Distension

Constipation

Diarrhea

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

APP Diary

Paper Diary

Study Details

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.

Conditions

Gas

Bloating

Distension

Constipation

Diarrhea

Study ID

NCT04684849

Start date

Sep 10, 2020

Status verified date

Jul, 2022

Completion date

Aug 31, 2024

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy subjects

Subjects who are healthy without disease

Gas and Bloating patients

Patients with symptoms of gas and bloating

Interventions

APP Diary

Subjects keep a multi- item electronic digital App survey of symptoms for 2 weeks

Paper Diary

Subjects keep a multi-item paper survey of symptoms for 2 weeks

Primary outcome measure

  • Correlation of electronic APP diary information with paper form gas and bloating diary in healthy subjects [ Time Frame: 2 weeks each ]
  • Correlation of electronic APP diary information with paper form gas and bloating diary in gas and bloating subjects [ Time Frame: 2 weeks each ]

Central Contacts and Locations

Central contacts

Locations

Augusta University

Recruiting

Augusta, Georgia, United States, 30912

More Information

Sponsor

Augusta University

Last update posted

Oct 24, 2022

Last verified

Jul, 2022

Keywords

  • Gas
  • Bloating
  • Distension
  • constipation
  • diarrhea

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Augusta University on 2022-10-24.