Gastro-intestinal Biopotential Recorder by Means of Surface ELEctrodes

Launched by CENTRAL HOSPITAL, NANCY, FRANCE · Jan 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how the electrical signals from the intestines differ among three groups: healthy individuals, patients with Crohn's disease who do not have scarring (fibrosis), and those who do have fibrosis, as well as patients with functional gastrointestinal disorders (FGID). The main goal is to see if there are noticeable differences in these signals between the groups. Additionally, the study will look into whether these signals relate to established measures of Crohn's disease and FGID, such as MRI results and specific questionnaires.

To participate, individuals must be over 18 years old and have fasted for at least 12 hours. Healthy volunteers should have no history of gastrointestinal diseases, while Crohn's disease patients need to have recent MRI and blood test results. Participants will undergo two recordings with a special device placed on their abdomen: the first will be during fasting, and the second will happen after they eat a standard meal. It's important to note that certain people, like those with pacemakers, severe allergies, or certain medical conditions, cannot participate. Overall, this trial aims to improve understanding of gastrointestinal health and potentially enhance how these conditions are diagnosed and treated.

Gender

ALL

Eligibility criteria

• 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