Crohn's Disease Clinical Trials

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Gastro-intestinal Biopotential Recorder by Means of Surface ELEctrodes

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

• Person has no history of chronic gastro-intestinal disease

• Person has no acute of gastro-intestinal disease

• 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

• 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

• Person is already diagnosed with functional gastrointestinal disorders

• Person has underwent an evaluation of the Rome IV criteria

Locations
Other Locations
France
CHRU de Nancy - Brabois
RECRUITING
Vandœuvre-lès-nancy
CHRU Nancy
RECRUITING
Vandœuvre-lès-nancy
Time Frame
Start Date: 2025-02-18
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 60
Treatments
Experimental: Healthy volunteers
Experimental: Crohn's disease patients with fibrosis
Experimental: Crohn's disease patients without fibrosis
Experimental: Functional gastrointestinal disorders patients
Related Therapeutic Areas
Sponsors
Leads: Central Hospital, Nancy, France

This content was sourced from clinicaltrials.gov