Assessment and Validation of Electronic Gas and Bloating Diary

Constipation Clinical Trial

Official title:

Assessment and Validation of Electronic Gas and Bloating Diary

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04684849
• Other study ID #: 1541299
• Status: Recruiting
• Start date: September 10, 2020
• Est. completion date: August 31, 2024

Study information

• Verified date: July 2022
• Source: Augusta University
• Contact: Satish Rao, MD PhD
• Phone: (706) 446-4887
• Email: srao[@]augusta.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Bloating
• Constipation
• Diarrhea
• Distension
• Gas

Intervention

Other:
• 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

Locations

Country	Name	City	State
United States	Augusta University	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

Outcome

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