Measuring stomach and bowel electrical signals with skin electrodes
Compares abdominal electrical signals in healthy adults, Crohn disease and functional gut disorders.
Plain-language title generated from the registry record
Registry title: Gastro-intestinal Biopotential Recorder by Means of Surface ELEctrodes
Key facts
- Where
- Vandœuvre-lès-Nancy, FranceSee the 2 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for healthy volunteers, people with Crohn's disease (with or without fibrosis), and people with functional gastrointestinal disorders. They wear a skin device on the belly to record gut signals.
- Age
- Older than 18 years
- Sex
- All sexes can join
- Disease stage
- Crohn's disease with fibrosis or without fibrosis, shown on an MRI done in the last 6 months; or functional gastrointestinal disorders already diagnosed.
- Biomarker or test result
- Crohn's disease groups need blood tests (C-reactive protein, fecal calprotectine) and a Harvey-Bradshaw Index questionnaire done in the last 6 months. Functional disorder group needs a Rome IV criteria evaluation.
Main reasons for not taking part
- Has a pacemaker
- Has had gastro-intestinal surgery
- Is allergic to the device or to soy, dairy food, peanuts, wheat or nuts
- Has an injury or redness on the belly skin
- Is in menstruation period
Read by machine on 12 November 2026.
Where in France
- Chru de Nancy-BraboisVandœuvre-lès-Nancy, FranceContact: Bénédicte Caron, MD, PhDTaking people
- CHRU NancyVandœuvre-lès-Nancy, FranceContact: DROUOT Guillaume, PhDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Central Hospital, Nancy, France
- Trial code
- NCT06197334
- Record updated
- 24 June 2026
- Original description
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.Read full original descriptionShow less
Gastro-intestinal Biopotential Recorder by Means of Surface ELEctrodes
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.
Inclusion: 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; Person has no history of chronic gastro-intestinal disease; Person has no acute of gastro-intestinal disease; 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; 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; Person is already diagnosed with functional gastrointestinal disorders; Person has underwent an evaluation of the Rome IV criteria.
Exclusion: 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 of legal age (subject to a legal protection measure); Person having a pacemaker; 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); Adult unable to give consent.