RecruitingNot ApplicableNCT06197334

Gastro-intestinal Biopotential Recorder by Means of Surface ELEctrodes


Sponsor

Central Hospital, Nancy, France

Enrollment

60 participants

Start Date

Feb 18, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Gastro-intestinal biopotentials recording for people with crohn disease, functional gastrointestinal disorders, and other related conditions. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEGastro-intestinal biopotentials recording

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, 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.


Locations(2)

CHRU Nancy

Vandœuvre-lès-Nancy, CHRU de Nancy, France

CHRU de Nancy - Brabois

Vandœuvre-lès-Nancy, France

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NCT06197334


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