NLP to Aid in the Evaluation and Diagnosis of FGIDs

Functional Gastrointestinal Disorders Clinical Trial

Official title:

Using Natural Language Processing of Novel Biopsychosocial Disease Constructs to Aid in the Evaluation and Diagnosis of Functional Gastrointestinal Disorders

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05501028
• Other study ID #: 2018P001542
• Status: Enrolling by invitation
• Start date: August 9, 2018
• Est. completion date: June 1, 2023

Study information

• Verified date: August 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study has two arms, where the same natural language processing (NLP) and probabilistic graphical modeling technology will be utilized on patients' report of symptoms in both arms. The clinical arm is focused on patients presenting for consultation with a gastroenterologist. The endoscopy arm is focused generally on patients presenting for a diagnostic endoscopy, with the goal of capturing Functional Gastrointestinal Disorder (FGID) patients prior to diagnosis.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 700
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Scheduled for consult in the Motility Clinic in the MGH Gastroenterology Unit or for diagnostic endoscopy in the MGH Gastroenterology Unit

• Patient must agree to have their interactions audio-recorded

• Informed consent form signed by the subjects

Exclusion Criteria:

• Non-native English speaker

• Patients unable to communicate their own symptoms

Related Conditions & MeSH terms

• Digestive System Diseases
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Massachusetts Institute of Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Latent themes present in patient descriptions of FGIDs symptoms	Latent themes present in patient descriptions of FGIDs symptoms as generated by machine learning as well as quantitative comparisons to traditional metrics of patient descriptions including Rome IV criteria and patient descriptions of severity.	08/09/2018-08/09/2023