GasNCT04684849
Assessment and Validation of Electronic Gas and Bloating Diary
An observational study of Gas and Bloating, run by Augusta University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gas, Bloating, Distension
- What is being tested?
- APP Diary and Paper Diary
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2020to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Anyone ages 18 to 80 years with constipation and gas and bloating symptoms.
Who may be able to join
- 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
- 1. Anyone 18 to 80 years of age, inclusive with no medical problems and a negative bowel disease screening questionnaire.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Augusta University
Augusta, Georgia, 30912
About this study
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.
Read the 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.
- Conditions
- Gas, Bloating, Distension, Constipation, Diarrhea
- Being tested
- APP Diary, Paper Diary
- Keywords
- Gas, Bloating, Distension, constipation, diarrhea
- Medical subject headings
- Mucopolysaccharidosis IV, Dilatation, Pathologic, Constipation, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APP DiaryOther
Subjects keep a multi- item electronic digital App survey of symptoms for 2 weeks
Paper DiaryOther
Subjects keep a multi-item paper survey of symptoms for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Subjects who are healthy without disease Receives: Other: APP Diary; Other: Paper Diary | |
| Gas and Bloating patients | Patients with symptoms of gas and bloating Receives: Other: APP Diary; Other: Paper Diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks each
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
Measured: 2 weeks each
Secondary outcomes (11)
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 .
Measured: 2 weeks each
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 .
Measured: 2 weeks each
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 .
Measured: 2 weeks each
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.
Measured: 2 weeks each
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.
Measured: 2 weeks each
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.
Measured: 2 weeks
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.
Measured: 2 weeks
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.
Measured: 2 weeks
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.
Measured: 2 weeks
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.
Measured: 2 weeks
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start10 Sep 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Satish Rao, Augusta University
- Investigators
- Satish Rao, MD PhD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684849
- Sponsor's protocol ID
- 1541299
- Status last verified
- Jul 2022
- First submitted
- 19 Nov 2020
- Last updated
- 24 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Validation of Electronic Gas and Bloating Diary
- ClinicalTrials.gov ID
- NCT04684849
- Acronym / sponsor ID
- 1541299
- Conditions
- Gas, Bloating, Distension, Constipation, Diarrhea
- Keywords
- Gas, Bloating, Distension, constipation, diarrhea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 28 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | Other: APP Diary, Other: Paper DiarySubjects who are healthy without disease |
| Gas and Bloating patients | – | Other: APP Diary, Other: Paper DiaryPatients with symptoms of gas and bloating |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Anyone ages 18 to 80 years with constipation and gas and bloating symptoms.
Key inclusion criteria (3 listed)
- 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
- 1. Anyone 18 to 80 years of age, inclusive with no medical problems and a negative bowel disease screening questionnaire.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APP DiarySubjects keep a multi- item electronic digital App survey of symptoms for 2 weeks | Other | Gas and Bloating patients, Healthy subjects |
| Paper DiarySubjects keep a multi-item paper survey of symptoms for 2 weeks | Other | Gas and Bloating patients, Healthy subjects |
Primary outcome
Correlation of electronic APP diary information with paper form gas and bloating diary in healthy subjects
Time frame: 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
Time frame: 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
11 secondary outcomes
Flatulence (Gas)
Time frame: 2 weeks each
Abdominal distension
Time frame: 2 weeks each
Bloating
Time frame: 2 weeks each
Abdominal Pain
Time frame: 2 weeks each
Belching
Time frame: 2 weeks each
Indigestion
Time frame: 2 weeks
Nausea
Time frame: 2 weeks
Vomiting
Time frame: 2 weeks
Number of Bowel Movements
Time frame: 2 weeks
Constipation
Time frame: 2 weeks
Diarrhea
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
Related trials for Gas
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Measurement of Expiratory Gas Temperature in Intubated Patients to Estimate Expiratory Absolute Humidity
Mechanical Ventilator Care
Active, not recruitingObservational study
Evaluation of Gas Humidification Practices in Patients Under Invasive Mechanical Ventilation
Humidifier Lung, Mechanical Fragility
RecruitingObservational study
A Multicenter Evaluation of SalivIQ™ Strep A for Detecting Group A Streptococcus From Saliva and Throat Swabs in Patients With Acute Pharyngitis
Streptococcal Pharyngitis, Group A Streptococcal Infection
Not yet recruitingPhase 3
Interest of Cryotherapy in Reducing Pain During Radial Arterial Blood Sampling
Chronic Respiratory Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Satish Rao, MD PhD principal investigator
Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gas and Bloating, run by Augusta University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Satish Rao, MD PhD ((706) 446-4887, srao@augusta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of electronic APP diary information with paper form gas and bloating diary in healthy subjects (time frame: 2 weeks each). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2022.