Crohn'sRecruiting
Gastro-intestinal Biopotential Recorder by Means of Surface ELEctrodes
Not applicable · Testing Gastro-intestinal biopotentials recording · 2 sites · Central Hospital, Nancy, France
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Gastro-intestinal biopotentials recording (a device) as a way to diagnose or measure disease. Condition(s) listed: Crohn Disease, Functional Gastrointestinal Disorders and Healthy.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- 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.
Plus 16 more requirement(s). There are also 13 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 60 participants are expected to take part.
- Start date: 2025-02-18.
- Main results expected around 2026-09-01 (estimate from the record).
- 2 study sites listed (2 marked recruiting) in France.
Main thing being measured
- Gastro-intestinal biopotentials pattern as recorded by the homemade recorder (12 months)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn Disease; Functional Gastrointestinal Disorders; Healthy |
| Lead sponsor | Central Hospital, Nancy, France |
| Enrollment | 60 (estimated) |
| Start date | 2025-02-18 |
| Primary completion (est.) | 2026-09-01 |
| First posted | 2024-01-09 |
| Last updated | 2026-06-24 |
| Official title | Gastro-intestinal Biopotential Recorder by Means of Surface ELEctrodes |
| ClinicalTrials.gov ID | NCT06197334 |
Interventions
- Gastro-intestinal biopotentials recording (Device)
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.
Full eligibility criteria (from the record)
Inclusion Criteria for all participants: * 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 Inclusion Criteria for healthy volunteers : * Person has no history of chronic gastro-intestinal disease * Person has no acute of gastro-intestinal disease Inclusion Criteria for Crohn's disease patients without fibrosis : * 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 Inclusion Criteria for Crohn's disease patients with fibrosis : * 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 Inclusion Criteria for functional gastrointestinal disorders patients : * Person is already diagnosed with functional gastrointestinal disorders * Person has underwent an evaluation of the Rome IV criteria Exclusion Criteria for all participants: * 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 * Person being allergic to : soy, dairy food, peanuts, wheat, nuts * Person having an history of gastro-intestinal surgery * Person suffering from injury or erythema on the abdominal skin * Person having a contagious potential (bacterial, fungal or viral) * Person being in menstruation period * Person suffering from urinary incontinence * Minor (not emancipated) * Person of legal age (subject to a legal protection measure) * Adult unable to give consent
Locations (2)
| Site | City | Country | Site status |
|---|---|---|---|
| CHRU de Nancy - Brabois | Vandœuvre-lès-Nancy | France | Recruiting |
| CHRU Nancy | Vandœuvre-lès-Nancy, CHRU de Nancy | France | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.