Clinical trial NCT04684849: Assessment and Validation of Electronic Gas and Bloating Diary
Official title: Assessment and Validation of Electronic Gas and Bloating Diary
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gas
Bloating
Distension
Constipation
Diarrhea
Keywords: Gas
Bloating
Distension
constipation
diarrhea
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Anyone ages 18 to 80 years with constipation and gas and bloating symptoms.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Correlation of electronic APP diary information with paper form gas and bloating diary in healthy subjects
timeFrame: 2 weeks each
measure: Correlation of electronic APP diary information with paper form gas and bloating diary in gas and bloating subjects
timeFrame: 2 weeks each
Secondary outcomes:
measure: Flatulence (Gas)
timeFrame: 2 weeks each
measure: Abdominal distension
timeFrame: 2 weeks each
measure: Bloating
timeFrame: 2 weeks each
measure: Abdominal Pain
timeFrame: 2 weeks each
measure: Belching
timeFrame: 2 weeks each
measure: Indigestion
timeFrame: 2 weeks
measure: Nausea
timeFrame: 2 weeks
measure: Vomiting
timeFrame: 2 weeks
measure: Number of Bowel Movements
timeFrame: 2 weeks
measure: Constipation
timeFrame: 2 weeks
measure: Diarrhea
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Augusta University
state: Georgia
Study officials:
affiliation: Augusta University
name: Satish Rao, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: