Assessment and Validation of Electronic Gas and Bloating Diary

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.

Study Overview

• Status: Recruiting
• Conditions: Constipation; Diarrhea; Bloating; Distension; Gas
• Intervention / Treatment: Other: APP Diary; Other: Paper 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 Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Satish Rao, MD PhD; Phone Number: (706) 446-4887; Email: srao@augusta.edu
• Study Contact Backup: Name: Yun Yan, PhD; Phone Number: 706-721-2263; Email: yyan@augusta.edu

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Recruiting
      • Augusta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Anyone ages 18 to 80 years with constipation and gas and bloating symptoms.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy subjects; Subjects who are healthy without disease	Other: APP Diary; Subjects keep a multi- item electronic digital App survey of symptoms for 2 weeks; Other: Paper Diary; Subjects keep a multi-item paper survey of symptoms for 2 weeks
Gas and Bloating patients; Patients with symptoms of gas and bloating	Other: APP Diary; Subjects keep a multi- item electronic digital App survey of symptoms for 2 weeks; Other: Paper Diary; Subjects keep a multi-item paper survey of symptoms for 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Augusta University
• Investigators: Principal Investigator: Satish Rao, MD PhD, Augusta University

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): August 31, 2024

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: December 21, 2020
• First Posted (Actual): December 28, 2020

Study Record Updates

• Last Update Posted (Actual): October 24, 2022
• Last Update Submitted That Met QC Criteria: October 21, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: diarrhea; Bloating; constipation; Gas; Distension
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Pathological Conditions, Anatomical; Diarrhea; Constipation; Dilatation, Pathologic
• Other Study ID Numbers: 1541299

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No