Gastro-intestinal Biopotential Recorder by Means of Surface ELEctrodes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentral Hospital, Nancy, France
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Gastro-intestinal biopotentials recording
DeviceParticipants 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, they 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.
Treatment groups
60 Participants
are divided into 4 treatment groupsGroup A: Healthy volunteersExperimental treatment 1 intervention
Group B: Crohn's disease patients with fibrosisExperimental treatment 1 intervention
Group C: Crohn's disease patients without fibrosisExperimental treatment 1 intervention
Group D: Functional gastrointestinal disorders patientsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Gastro-intestinal biopotentials pattern as recorded by the homemade recorder
Gastro-intestinal biopotentials pattern in patients versus healthy volunteers
Time frame
12 monthsSecondary outcomes
1
Correlation score between gastro-intestinal biopotentials pattern as recorded by the homemade recorder vs Harvey-Bradshaw Index assessed with a questionnaire
Correlation score in Crohn's disease patients with and without fibrosis for the gastro-intestinal biopotentials pattern vs the Harvey-Bradshaw Index
Time frame
12 months2
Correlation score between gastro-intestinal biopotentials pattern as recorded by the homemade recorder vs the Nancy score assessed by a clinician rating MRI images
Correlation score in Crohn's disease patients with and without fibrosis for the gastro-intestinal biopotentials pattern vs the Nancy score (MRI score)
Time frame
12 months3
Correlation score between gastro-intestinal biopotentials pattern as recorded by the homemade recorder vs blood fecal calprotectin levels (µg/g)
Correlation score in Crohn's disease patients with and without fibrosis for the gastro-intestinal biopotentials pattern vs blood fecal calprotectin levels
Time frame
12 months4
Correlation score between gastro-intestinal biopotentials pattern as recorded by the homemade recorder vs C-reactive protein levels (µg/L)
Correlation score in Crohn's disease patients with and without fibrosis for the gastro-intestinal biopotentials pattern vs C-reactive protein levels
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov