Myoelectric GutPrint-Crohn's Disease (Gutcheck-CD)

October 3, 2023 updated by: Sidhartha Ranjit Sinha, Stanford University

Longitudinal Study of Myoelectric GutPrint of Healthy Controls and Crohn's Disease Patients During Flare and Remission

A feasibility study for assessing and recording myoelectric activity in patients for early detection of flare in patients with Crohn's disease and differentiating the myoelectric signals from Crohn's disease patients in remission state and healthy controls.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Crohn's disease (CD) patients can have a chronic, relapsing course with frequent flares despite aggressive therapy. Flares are often difficult to predict. The goal of disease monitoring is to identify patients at risk for flare in order to treat earlier, with the hope of maintaining remission and avoiding irreversible bowel damage such as fistulas and strictures that may lead to surgery. Although endoscopic visualization of the mucosa allows in some cases ability to predict flare and determine deep remission, this procedure is invasive and requires anesthesia and a bowel preparation, and is not without risk. Abdominal pain, cramps and diarrhea are particularly common symptoms of CD, which are associated with alteration of gastrointestinal (GI) motility. Thus better understanding of GI motility patterns in CD flare and remission states may be helpful for prediction of flare for guiding appropriate therapy.

The goal of this study is to determine whether the motility patterns measured by the G-Tech non-invasive, wireless patch system can provide useful insight for routine CD care. Three G-Tech patches will be placed on the patients' abdomen and they will be given an iPod Touch to carry with them for the next 3-6 days. Data from the patches is processed offline to obtain motility patterns of the stomach, small intestine and colon. These patterns represent a rich trove of data that can be studied in multiple ways to provide comparisons and insight. Some examples are the overall strength of motor activity in each of the organs, the duration and rhythmicity, the correlation with meals, pain events and bowel movements, day to day variations and their correlation with symptoms, and diurnal effects.

Study Type

Observational

Enrollment (Actual)

136

Contacts and Locations

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

Study Contact

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94305
        • Stanford University

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy subjects without gastrointestinal symptoms or history of gastrointestinal surgeries.

Patients with Crohn's disease in remission state or flare state (exclude severe Crohn's disease due to complexity of disease, complication, and potential needs for surgery; on new medications 【e.g. within 3 months of enrollment】 known to alter GI motility or bowel surgeries due to potential impact on the G-Tech results)

Description

Inclusion Criteria:

  • Patients with Crohn's disease and healthy subjects above the age of 18 who are able to give consent and follow direction.

Exclusion Criteria:

  • Patients or subjects under the age of 18, pregnant, and those unable to give consent or follow direction.
  • Healthy subjects with gastrointestinal symptoms or history of gastrointestinal surgeries.
  • Patients with severe Crohn's disease due to complexity of disease, complication, and potential needs for surgery.
  • Patients with bowel surgeries due to potential impact on the G-Tech results. For similar reasons we will exclude patients on new medications (e.g. within 3 months of enrollment) known to alter GI motility but we will not exclude patients on stable doses or chronic GI motility agents as this mimics "real world" in which the G-Tech patch will be used and we can learn the stability of the motility recordings over time in stable patients.

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
Intervention / Treatment
Healthy controls
Record gastrointestinal motility by G-Tech Gutcheck Myoelectric recording device in healthy controls. The investigator does not change the routine medical care of study participants.
Device: G-Tech Gutcheck Myoelectric recording device
Three G-Tech patches are placed on the abdomen of the patient to record myoelectric activity.
Other Names:
  • Gastro-intestinal electrical recording
Crohn's disease (remission state)
Record gastrointestinal motility by G-Tech Gutcheck Myoelectric recording device in subjects with Crohn's disease (remission state). The investigator does not change the routine medical care of study participants.
Device: G-Tech Gutcheck Myoelectric recording device
Three G-Tech patches are placed on the abdomen of the patient to record myoelectric activity.
Other Names:
  • Gastro-intestinal electrical recording
Crohn's disease (flare state)
Record gastrointestinal motility by G-Tech Gutcheck Myoelectric recording device in subjects with Crohn's disease (flare state). The investigator does not change the routine medical care of study participants.
Device: G-Tech Gutcheck Myoelectric recording device
Three G-Tech patches are placed on the abdomen of the patient to record myoelectric activity.
Other Names:
  • Gastro-intestinal electrical recording

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myoelectric activity pattern (physiological parameters)
Time Frame: change from baseline at 1 month, 3 months and 6 months after recruitment
Myoelectric activity pattern in Crohn's disease patients versus healthy controls
change from baseline at 1 month, 3 months and 6 months after recruitment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of anticipated Adverse Events
Time Frame: Up to 6 days
Device related anticipated adverse events; such as, skin irritation due to adhesive from the skin patch.
Up to 6 days
Number of unanticipated adverse device effects
Time Frame: Up to 6 days
Unanticipated adverse device effects
Up to 6 days

Collaborators and Investigators

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

Sponsor

Stanford University

Collaborators

G-Tech Corporation
The Leona M. and Harry B. Helmsley Charitable Trust

Investigators

  • Principal Investigator: Sidhartha Sinha, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2019

Primary Completion (Actual)

March 31, 2023

Study Completion (Actual)

June 15, 2023

Study Registration Dates

First Submitted

November 29, 2018

First Submitted That Met QC Criteria

December 10, 2018

First Posted (Actual)

December 13, 2018

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

October 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB48539

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We will share the data through publication of results. Individual participant data was not promised to be shared.

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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