NLP to Aid in the Evaluation and Diagnosis of FGIDs

April 30, 2026 updated by: Kyle Staller, MD, MPH, Massachusetts General Hospital

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Study Type

Observational

Enrollment (Estimated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Group 1: Patients who are scheduled for a consult in the MGH Gastroenterology Unit

Group 2: Patients who are scheduled for a diagnostic endoscopy in the MGH Gastroenterology Unit

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients scheduled for consult with gastroenterologist
Patients scheduled for diagnostic endoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Latent themes present in patient descriptions of FGIDs symptoms
Time Frame: 08/09/2018-08/09/2023
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Massachusetts Institute of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2018

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 1, 2022

First Submitted That Met QC Criteria

August 12, 2022

First Posted (Actual)

August 15, 2022

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018P001542

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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