NCT05501028

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Aug 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Aug 2018Dec 2026

Study Start

First participant enrolled

August 9, 2018

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2022

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 15, 2022

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

May 6, 2026

Status Verified

November 1, 2025

Enrollment Period

8.3 years

First QC Date

March 1, 2022

Last Update Submit

April 30, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Patients scheduled for consult with gastroenterologist

Patients scheduled for diagnostic endoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • Non-native English speaker
  • Patients unable to communicate their own symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 1, 2022

First Posted

August 15, 2022

Study Start

August 9, 2018

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 6, 2026

Record last verified: 2025-11

Locations