Gastro-intestinal Biopotential Recorder by Means of Surface ELEctrodes (NCT06197334) | Clinical Trial Compass
RecruitingNot Applicable
Gastro-intestinal Biopotential Recorder by Means of Surface ELEctrodes
France60 participantsStarted 2025-02-18
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 insen…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Gastro-intestinal biopotentials pattern as recorded by the homemade recorder