Clinical trial NCT06197334: Gastro-intestinal Biopotential Recorder by Means of Surface ELEctrodes
Official title: Gastro-intestinal Biopotential Recorder by Means of Surface ELEctrodes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Crohn Disease
Functional Gastrointestinal Disorders
Healthy
Keywords: Medical device
Electrophysiology
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: Diseases and disorders of the digestive tract affect a large proportion of the world's population. These disorders or diseases degrade patients' quality of life and are costly for healthcare systems. Today, it is difficult to categorize, monitor and/or prognosticate their evolution due to their unknown etiologies, the long duration of the digestion processes and unsuitable (invasive, complex or costly) examinations.

However, electrophysiology holds great promise for the study of these diseases. Indeed, the organs of the digestive tract are made up of longitudinal and circular muscles which contract rhythmically and synchronously to advance the food bolus during digestion, or to cleanse the digestive tract once digestion is complete.

No study has yet demonstrated the feasibility and value of measuring these bio-potentials for Functional Gastro Intestinal Disorders and Inflammatory Bowel Diseases.

That's why a homemade gastro-intestinal biopotentials recorder was developped. The recorder uses surface electrodes placed on the abdomen to record this biopotentials. The investigators hypothesize that surface gastro-intestinal biopotentials differ between a population of healthy volunteers, Crohn's disease patients and FGID patients.

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

Primary outcomes:
measure: Gastro-intestinal biopotentials pattern as recorded by the homemade recorder
timeFrame: 12 months
Secondary outcomes:
measure: Correlation score between gastro-intestinal biopotentials pattern as recorded by the homemade recorder vs Harvey-Bradshaw Index assessed with a questionnaire
timeFrame: 12 months
measure: Correlation score between gastro-intestinal biopotentials pattern as recorded by the homemade recorder vs the Nancy score assessed by a clinician rating MRI images
timeFrame: 12 months
measure: Correlation score between gastro-intestinal biopotentials pattern as recorded by the homemade recorder vs blood fecal calprotectin levels (µg/g)
timeFrame: 12 months
measure: Correlation score between gastro-intestinal biopotentials pattern as recorded by the homemade recorder vs C-reactive protein levels (µg/L)
timeFrame: 12 months
measure: Correlation score between gastro-intestinal biopotentials pattern as recorded by the homemade recorder vs Rome IV criteria
timeFrame: 12 months
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU de Nancy - Brabois
Study officials:
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