Status:
UNKNOWN
Assessment and Validation of Electronic Gas and Bloating Diary
Lead Sponsor:
Augusta University
Conditions:
Gas
Bloating
Eligibility:
All Genders
18-80 years
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 ...
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 ...
Eligibility Criteria
Inclusion
- Inclusion/Exclusion for gas and bloating subjects:
- Inclusion:
- 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.
- 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:
- Women of childbearing age will be asked if they are pregnant, and a negative response will be sufficient. No pregnancy test will be performed.
- History of previous GI surgeries (except for cholecystectomy, hysterectomy, and appendectomy)
- Significant co-morbid medical conditions, including stroke, COPD( Chronic Obstructive Pulmonary Disease) and cancers (except for non-melanotic skin cancer)
- Recent hospitalization within 30 days of enrollment in this study
- Recent History (within 4 weeks) of antibiotic use
- 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.
Exclusion
Key Trial Info
Start Date :
September 10 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04684849
Start Date
September 10 2020
End Date
August 31 2024
Last Update
October 24 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Augusta University
Augusta, Georgia, United States, 30912