Assessment and Validation of Electronic Gas and Bloating Diary

NCT04684849 | Unknown

• 1 other identifier: 1541299
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Gas; Bloating; Distension; Constipation; Diarrhea

Keywords

Gas; Bloating; Distension; constipation; diarrhea

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Flatulence (Gas)

  2 weeks each

• Abdominal distension

  2 weeks each

• Bloating

  2 weeks each

• Abdominal Pain

  2 weeks each

• Belching

  2 weeks each

Study Arms (2)

Healthy subjects

Subjects who are healthy without disease

Other: APP Diary; Other: Paper Diary

Gas and Bloating patients

Patients with symptoms of gas and bloating

Other: APP Diary; Other: Paper Diary

Interventions

APP Diary OTHER

Subjects keep a multi- item electronic digital App survey of symptoms for 2 weeks

Gas and Bloating patients; Healthy subjects

Paper Diary OTHER

Subjects keep a multi-item paper survey of symptoms for 2 weeks

Gas and Bloating patients; Healthy subjects

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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
• \. Anyone 18 to 80 years of age, inclusive with no medical problems and a negative bowel disease screening questionnaire.

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Augusta University

Augusta, Georgia, 30912, United States

RECRUITING

MeSH Terms

Conditions

Mucopolysaccharidosis IV; Dilatation, Pathologic; Constipation; Diarrhea

Condition Hierarchy (Ancestors)

Mucopolysaccharidoses; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lysosomal Storage Diseases; Mucinoses; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Study Officials

• Satish Rao, MD PhD

  Augusta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Satish Rao, MD PhD

CONTACT

(706) 446-4887; srao@augusta.edu

Yun Yan, PhD

CONTACT

706-721-2263; yyan@augusta.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: December 28, 2020
• Study Start: September 10, 2020
• Primary Completion: December 31, 2023
• Study Completion: August 31, 2024
• Last Updated: October 24, 2022

Record last verified: 2022-07

Locations

US (1)