Constipation Clinical Trial
Official title:
Assessment and Validation of Electronic Gas and Bloating Diary
NCT number | NCT04684849 |
Other study ID # | 1541299 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 10, 2020 |
Est. completion date | August 31, 2024 |
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | August 31, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Augusta University | Augusta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Augusta University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlation of electronic APP diary information with paper form gas and bloating diary in healthy subjects | 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 | 2 weeks each | |
Primary | Correlation of electronic APP diary information with paper form gas and bloating diary in gas and bloating subjects | 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 | 2 weeks each | |
Secondary | Flatulence (Gas) | 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 . | 2 weeks each | |
Secondary | Abdominal distension | 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 . | 2 weeks each | |
Secondary | Bloating | 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 . | 2 weeks each | |
Secondary | Abdominal Pain | 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. | 2 weeks each | |
Secondary | Belching | 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. | 2 weeks each | |
Secondary | Indigestion | 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. | 2 weeks | |
Secondary | Nausea | 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. | 2 weeks | |
Secondary | Vomiting | 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. | 2 weeks | |
Secondary | Number of Bowel Movements | 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. | 2 weeks | |
Secondary | Constipation | 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. | 2 weeks | |
Secondary | Diarrhea | 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. | 2 weeks |
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