Gastro-intestinal biopotentials recordings using a腹 surface device across healthy people and digestive disease patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study compares gastro-intestinal biopotentials recorded with a noninvasive abdominal device across four groups: healthy volunteers, Crohn’s disease patients without fibrosis, Crohn’s disease patients with fibrosis, and those with functional GI disorders. Participants undergo two recording sessions after fasting, with a standardized meal, to capture gut electrical signals. The study also explores how these biopotentials align with established medical measures such as Harvey-Bradshaw Index, MRI results, fecal calprotectin, and Rome IV criteria. The device is a homemade recorder using surface abdominal electrodes to capture signals during the digestive process. The design is exploratory and aims to establish feasibility and potential clinical relevance of GI biopotential recordings.

Why it matters

Who can join: the full rules

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

Where it's running

• CHRU Nancy
  Vandœuvre-lès-Nancy, CHRU de Nancy, France Recruiting
• CHRU de Nancy - Brabois
  Vandœuvre-lès-Nancy, France Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.