NCT06197334Recruiting
Gastro-intestinal Biopotential Recorder by Means of Surface ELEctrodes
Source: ClinicalTrials.gov · Last updated 24 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 19 Dec 2023
- Start date
- 18 Feb 2025
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- Central Hospital, Nancy, France
- Diseases
- Crohn's disease
- NCT number
- NCT06197334
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 18 Feb 2025 to the primary completion date, 1 Sept 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Age
- Person of legal age (subject to a legal protection measure)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHRU Nancy Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Recruiting |
| Chru de Nancy-Brabois Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.