Gastro-intestinal Biopotential Recorder by Means of Surface ELEctrodes

Not Applicable

Not yet recruiting

• Conditions: Healthy; Functional Gastrointestinal Disorders; Crohn Disease
• Interventions: Device: Gastro-intestinal biopotentials recording

• Registration Number: NCT06197334
• Lead Sponsor: Central Hospital, Nancy, France

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.

Study Timeline

• Study First Submitted: 2023-12-19
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-08
• Last Update Submitted: 2024-01-08
• Study First Posted: 2024-01-09
• Last Update Posted: 2024-01-09
• Study Start: 2024-03-01
• Primary Completion: 2025-03-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Crohn's disease patients with fibrosis	Gastro-intestinal biopotentials recording	-
Healthy volunteers	Gastro-intestinal biopotentials recording	-
Crohn's disease patients without fibrosis	Gastro-intestinal biopotentials recording	-
Functional gastrointestinal disorders patients	Gastro-intestinal biopotentials recording	-

Primary Outcome Measures

Name	Time	Method
Gastro-intestinal biopotentials pattern as recorded by the homemade recorder	12 months	Gastro-intestinal biopotentials pattern in patients versus healthy volunteers

Secondary Outcome Measures

Name	Time	Method
Correlation score between gastro-intestinal biopotentials pattern as recorded by the homemade recorder vs blood fecal calprotectin levels (µg/g)	12 months	Correlation score in Crohn's disease patients with and without fibrosis for the gastro-intestinal biopotentials pattern vs blood fecal calprotectin levels
Correlation score between gastro-intestinal biopotentials pattern as recorded by the homemade recorder vs C-reactive protein levels (µg/L)	12 months	Correlation score in Crohn's disease patients with and without fibrosis for the gastro-intestinal biopotentials pattern vs C-reactive protein levels
Correlation score between gastro-intestinal biopotentials pattern as recorded by the homemade recorder vs Harvey-Bradshaw Index assessed with a questionnaire	12 months	Correlation score in Crohn's disease patients with and without fibrosis for the gastro-intestinal biopotentials pattern vs the Harvey-Bradshaw Index
Correlation score between gastro-intestinal biopotentials pattern as recorded by the homemade recorder vs the Nancy score assessed by a clinician rating MRI images	12 months	Correlation score in Crohn's disease patients with and without fibrosis for the gastro-intestinal biopotentials pattern vs the Nancy score (MRI score)
Correlation score between gastro-intestinal biopotentials pattern as recorded by the homemade recorder vs Rome IV criteria	12 months	Correlation score in functional gastrointestinal disorders patients for the gastro-intestinal biopotentials pattern vs the Rome IV criteria

Trial Locations

Locations (1)

CHRU de Nancy - Brabois; 🇫🇷 Vandœuvre-lès-Nancy, France