Gastro-intestinal Biopotential Recorder by Means of Surface ELEctrodes (GRELE)

January 8, 2024 updated by: CARON Bénédicte, Central Hospital, Nancy, France

The goal of this clinical trial is to compare the gastro-intestinal biopotentials recorded with a homemade device using surface electrodes placed on the abdomen in healthy volunteers, Crohn's disease patients without fibrosis, Crohn's disease patients with fibrosis and in functional gastrointestinal disorders (FGID) patients.

The main question it aims to answer is:

• Is there any differences in the gastro-intestinal biopotentials between the different populations under study?

It aims to answer two secondary questions:

  • Are the gastro-intestinal biopotentials comparable to the Harvey-Bradshaw Index, MRI and biological data for patients with Crohn's disease?
  • Are the gastro-intestinal biopotentials comparable to Rome IV criteria for functional gastrointestinal disorders patients?

Participants will undertake two recordings made with the device. The first one will last 1 hour and 30 minutes and will occurs while the participants are fasting. Then, the participants will eat a standardized meal. Finally, the second recording will take place after the meal ingestion and will last 1 hour and 30 minutes while the participants are in postprandial state.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Diseases and disorders of the digestive tract affect a large proportion of the world's population. These disorders or diseases degrade patients' quality of life and are costly for healthcare systems. Today, it is difficult to categorize, monitor and/or prognosticate their evolution due to their unknown etiologies, the long duration of the digestion processes and unsuitable (invasive, complex or costly) examinations.

However, electrophysiology holds great promise for the study of these diseases. Indeed, the organs of the digestive tract are made up of longitudinal and circular muscles which contract rhythmically and synchronously to advance the food bolus during digestion, or to cleanse the digestive tract once digestion is complete.

No study has yet demonstrated the feasibility and value of measuring these bio-potentials for Functional Gastro Intestinal Disorders and Inflammatory Bowel Diseases.

That's why a homemade gastro-intestinal biopotentials recorder was developped. The recorder uses surface electrodes placed on the abdomen to record this biopotentials. The investigators hypothesize that surface gastro-intestinal biopotentials differ between a population of healthy volunteers, Crohn's disease patients and FGID patients.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

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

  • France
      • Vandœuvre-lès-Nancy, France, 54500
        • CHRU de Nancy - Brabois

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria for all participants:

  • Person age > 18 years
  • Person has been fasting for at least 12 hours
  • Person who has received full information on the organization of the research and has not objected to the use of this data.
  • Person affiliated to or beneficiary of a social security plan
  • Person informed about study organization and having signed the informed consent

Inclusion Criteria for healthy volunteers :

  • Person has no history of chronic gastro-intestinal disease
  • Person has no acute of gastro-intestinal disease

Inclusion Criteria for Crohn's disease patients without fibrosis :

  • Person is already diagnosed with Crohn's disease
  • Person has underwent during the last 6 months :
  • An MRI showing no fibrosis
  • A blood test for C-reactive protein and fecal calprotectine
  • A questionnaire to asses the Harvey-Bradshaw Index

Inclusion Criteria for Crohn's disease patients with fibrosis :

  • Person is already diagnosed with Crohn's disease
  • Person has underwent during the last 6 months :
  • An MRI showing fibrosis
  • A blood test for C-reactive protein and fecal calprotectine
  • A questionnaire to asses the Harvey-Bradshaw Index

Inclusion Criteria for functional gastrointestinal disorders patients :

  • Person is already diagnosed with functional gastrointestinal disorders
  • Person has underwent an evaluation of the Rome IV criteria

Exclusion Criteria for all participants:

  • Person having a pacemaker
  • Person suffering from a sensory disorder making insensitive to pain on the skin
  • Person suffering from a mental or motor disorders creating uncontroled movements
  • Person being allergic to one or more component of the device
  • Person being allergic to : soy, dairy food, peanuts, wheat, nuts
  • Person having an history of gastro-intestinal surgery
  • Person suffering from injury or erythema on the abdominal skin
  • Person having a contagious potential (bacterial, fungal or viral)
  • Person being in menstruation period
  • Person suffering from urinary incontinence
  • Minor (not emancipated)
  • Person of legal age (subject to a legal protection measure)
  • Adult unable to give consent

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

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy volunteers
Device: Gastro-intestinal biopotentials recording
Participants will undertake two recordings made with the device. The first one will last 1 hour and 30 minutes and will occurs while the participants are fasting. Then, they will eat a standardized meal. Finally, the second recording will take place after the meal ingestion and will last 1 hour and 30 minutes while the participants are in postprandial state.
Experimental: Crohn's disease patients with fibrosis
Device: Gastro-intestinal biopotentials recording
Participants will undertake two recordings made with the device. The first one will last 1 hour and 30 minutes and will occurs while the participants are fasting. Then, they will eat a standardized meal. Finally, the second recording will take place after the meal ingestion and will last 1 hour and 30 minutes while the participants are in postprandial state.
Experimental: Crohn's disease patients without fibrosis
Device: Gastro-intestinal biopotentials recording
Participants will undertake two recordings made with the device. The first one will last 1 hour and 30 minutes and will occurs while the participants are fasting. Then, they will eat a standardized meal. Finally, the second recording will take place after the meal ingestion and will last 1 hour and 30 minutes while the participants are in postprandial state.
Experimental: Functional gastrointestinal disorders patients
Device: Gastro-intestinal biopotentials recording
Participants will undertake two recordings made with the device. The first one will last 1 hour and 30 minutes and will occurs while the participants are fasting. Then, they will eat a standardized meal. Finally, the second recording will take place after the meal ingestion and will last 1 hour and 30 minutes while the participants are in postprandial state.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastro-intestinal biopotentials pattern as recorded by the homemade recorder
Time Frame: 12 months
Gastro-intestinal biopotentials pattern in patients versus healthy volunteers
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation score between gastro-intestinal biopotentials pattern as recorded by the homemade recorder vs Harvey-Bradshaw Index assessed with a questionnaire
Time Frame: 12 months
Correlation score in Crohn's disease patients with and without fibrosis for the gastro-intestinal biopotentials pattern vs the Harvey-Bradshaw Index
12 months
Correlation score between gastro-intestinal biopotentials pattern as recorded by the homemade recorder vs the Nancy score assessed by a clinician rating MRI images
Time Frame: 12 months
Correlation score in Crohn's disease patients with and without fibrosis for the gastro-intestinal biopotentials pattern vs the Nancy score (MRI score)
12 months
Correlation score between gastro-intestinal biopotentials pattern as recorded by the homemade recorder vs blood fecal calprotectin levels (µg/g)
Time Frame: 12 months
Correlation score in Crohn's disease patients with and without fibrosis for the gastro-intestinal biopotentials pattern vs blood fecal calprotectin levels
12 months
Correlation score between gastro-intestinal biopotentials pattern as recorded by the homemade recorder vs C-reactive protein levels (µg/L)
Time Frame: 12 months
Correlation score in Crohn's disease patients with and without fibrosis for the gastro-intestinal biopotentials pattern vs C-reactive protein levels
12 months
Correlation score between gastro-intestinal biopotentials pattern as recorded by the homemade recorder vs Rome IV criteria
Time Frame: 12 months
Correlation score in functional gastrointestinal disorders patients for the gastro-intestinal biopotentials pattern vs the Rome IV criteria
12 months

Collaborators and Investigators

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

Sponsor

Central Hospital, Nancy, France

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 (Estimated)

March 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

December 19, 2023

First Submitted That Met QC Criteria

January 8, 2024

First Posted (Actual)

January 9, 2024

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-A01618-37

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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