Gastro-intestinal Biopotential Recorder by Means of Surface ELEctrodes
Recruiting · NCT06197334 · Interventional (participants receive a specific treatment) · Lead sponsor: Central Hospital, Nancy, France
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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
Where it is running
2 locations listed.
- CHRU de Nancy - Brabois - Vandœuvre-lès-Nancy, France
- CHRU Nancy - Vandœuvre-lès-Nancy, CHRU de Nancy, France