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Gastro-intestinal Biopotential Recorder by Means of Surface ELEctrodes

Study acronym: GRELE
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated June 24, 2026 (before its estimated September 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Mar 1, 2025 to Sep 1, 2026
    • Start date changed from estimate of Mar 1, 2024 to Feb 18, 2025
    • Study sites: 1 to 2
    • Study completion date: Sep 1, 2025 to Sep 1, 2027
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06197334
Lead Sponsor Central Hospital, Nancy, France
Conditions
(from sponsor)		 Crohn Disease, Functional Gastrointestinal Disorders, Healthy
Related terms Crohn Disease, Gastrointestinal Diseases
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov