Crohn DiseaseGRELENCT06197334
Gastro-intestinal Biopotential Recorder by Means of Surface ELEctrodes
A study testing Gastro-intestinal biopotentials recording in people with Crohn Disease and Functional Gastrointestinal Disorders, run by Central Hospital, Nancy, France at 2 sites in France.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Crohn Disease, Functional Gastrointestinal Disorders, Healthy
- What is being tested?
- Gastro-intestinal biopotentials recording
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 18 Feb 2025to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 22Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CHRU Nancy
Vandœuvre-lès-Nancy, CHRU de Nancy, 54511
DROUOT Guillaume, PhD, 0383157666, g.drouot@chru-nancy.fr
Bénédicte CARON, MD, PhD
- Recruiting
CHRU de Nancy - Brabois
Vandœuvre-lès-Nancy, 54500
Bénédicte Caron, MD, PhD, +33 3 83 15 50 49, b.caron@chru-nancy.fr
Guillaume Drouot, PhD, +33 3 83 15 76 66, g.drouot@chru-nancy.fr
About this study
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:
Read more
- 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.
Read the 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.
- Being tested
- Gastro-intestinal biopotentials recording
- Keywords
- Medical device, Electrophysiology
- Medical subject headings
- Crohn Disease, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastro-intestinal biopotentials recordingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Experimental | Not described Receives: Device: Gastro-intestinal biopotentials recording |
| Crohn's disease patients with fibrosis | Experimental | Not described Receives: Device: Gastro-intestinal biopotentials recording |
| Crohn's disease patients without fibrosis | Experimental | Not described Receives: Device: Gastro-intestinal biopotentials recording |
| Functional gastrointestinal disorders patients | Experimental | Not described Receives: Device: Gastro-intestinal biopotentials recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastro-intestinal biopotentials pattern as recorded by the homemade recorder
Gastro-intestinal biopotentials pattern in patients versus healthy volunteers
Measured: 12 months
Secondary outcomes (5)
Correlation score between gastro-intestinal biopotentials pattern as recorded by the homemade recorder vs Harvey-Bradshaw Index assessed with a questionnaire
Correlation score in Crohn's disease patients with and without fibrosis for the gastro-intestinal biopotentials pattern vs the Harvey-Bradshaw Index
Measured: 12 months
Correlation score between gastro-intestinal biopotentials pattern as recorded by the homemade recorder vs the Nancy score assessed by a clinician rating MRI images
Correlation score in Crohn's disease patients with and without fibrosis for the gastro-intestinal biopotentials pattern vs the Nancy score (MRI score)
Measured: 12 months
Correlation score between gastro-intestinal biopotentials pattern as recorded by the homemade recorder vs blood fecal calprotectin levels (µg/g)
Correlation score in Crohn's disease patients with and without fibrosis for the gastro-intestinal biopotentials pattern vs blood fecal calprotectin levels
Measured: 12 months
Correlation score between gastro-intestinal biopotentials pattern as recorded by the homemade recorder vs C-reactive protein levels (µg/L)
Correlation score in Crohn's disease patients with and without fibrosis for the gastro-intestinal biopotentials pattern vs C-reactive protein levels
Measured: 12 months
Correlation score between gastro-intestinal biopotentials pattern as recorded by the homemade recorder vs Rome IV criteria
Correlation score in functional gastrointestinal disorders patients for the gastro-intestinal biopotentials pattern vs the Rome IV criteria
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start18 Feb 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CARON Bénédicte, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197334
- Sponsor's protocol ID
- 2023-A01618-37
- Acronym
- GRELE
- Status last verified
- Jun 2026
- First submitted
- 19 Dec 2023
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alighaleh S, Cheng L, Angeli-Gordon TR, Aghababaie Z, O'Grady G, Paskaranandavadivel N. Design and Validation of a Surface-Contact Electrode for Gastric Pacing and Concurrent Slow-Wave Mapping. IEEE Trans Biomed Eng. 2021 Aug;68(8):2574-2581. doi: 10.1109/TBME.2021.3063685. Epub 2021 Jul 16.
PubMed 33656985Axelrod L, Axelrod S, Navalgund A, Triadafilopoulos G. Pilot Validation of a New Wireless Patch System as an Ambulatory, Noninvasive Tool That Measures Gut Myoelectrical Signals: Physiologic and Disease Correlations. Dig Dis Sci. 2021 Oct;66(10):3505-3515. doi: 10.1007/s10620-020-06663-y. Epub 2020 Oct 15.
PubMed 33063188Bassotti G, Antonelli E, Villanacci V, Salemme M, Coppola M, Annese V. Gastrointestinal motility disorders in inflammatory bowel diseases. World J Gastroenterol. 2014 Jan 7;20(1):37-44. doi: 10.3748/wjg.v20.i1.37.
PubMed 24415856Calder S, Cheng LK, Andrews CN, Paskaranandavadivel N, Waite S, Alighaleh S, Erickson JC, Gharibans A, O'Grady G, Du P. Validation of noninvasive body-surface gastric mapping for detecting gastric slow-wave spatiotemporal features by simultaneous serosal mapping in porcine. Am J Physiol Gastrointest Liver Physiol. 2022 Oct 1;323(4):G295-G305. doi: 10.1152/ajpgi.00049.2022. Epub 2022 Aug 2.
PubMed 35916432Erickson JC, Bruce LE, Taylor A, Richman J, Higgins C, Wells CI, O'Grady G. Electrocolonography: Non-Invasive Detection of Colonic Cyclic Motor Activity From Multielectrode Body Surface Recordings. IEEE Trans Biomed Eng. 2020 Jun;67(6):1628-1637. doi: 10.1109/TBME.2019.2941851. Epub 2019 Sep 16.
PubMed 31535980Gharibans AA, Hayes TCL, Carson DA, Calder S, Varghese C, Du P, Yarmut Y, Waite S, Keane C, Woodhead JST, Andrews CN, O'Grady G. A novel scalable electrode array and system for non-invasively assessing gastric function using flexible electronics. Neurogastroenterol Motil. 2023 Feb;35(2):e14418. doi: 10.1111/nmo.14418. Epub 2022 Jun 14.
PubMed 35699340Huizinga JD, Lammers WJ. Gut peristalsis is governed by a multitude of cooperating mechanisms. Am J Physiol Gastrointest Liver Physiol. 2009 Jan;296(1):G1-8. doi: 10.1152/ajpgi.90380.2008. Epub 2008 Nov 6.
PubMed 18988693Khan, M.U., Aziz, S., Sohail, M., Shahid, A.A., Samer, S., 2019. Automated Detection and Classification of Gastrointestinal Diseases using surface-EMG Signals, in: 2019 22nd International Multitopic Conference (INMIC). IEEE, pp. 1-8. https://doi.org/10.1109/INMIC48123.2019.9022741
Navalgund, A., Axelrod, S., Triadafilopoulos, G., 2015. Feasibility of measuring the contractile electrical complex over 72 hours in a healthy human subject using a wearable, wireless electrode patch.
Ng SC, Shi HY, Hamidi N, Underwood FE, Tang W, Benchimol EI, Panaccione R, Ghosh S, Wu JCY, Chan FKL, Sung JJY, Kaplan GG. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. Lancet. 2017 Dec 23;390(10114):2769-2778. doi: 10.1016/S0140-6736(17)32448-0. Epub 2017 Oct 16.
PubMed 29050646Peery AF, Crockett SD, Murphy CC, Lund JL, Dellon ES, Williams JL, Jensen ET, Shaheen NJ, Barritt AS, Lieber SR, Kochar B, Barnes EL, Fan YC, Pate V, Galanko J, Baron TH, Sandler RS. Burden and Cost of Gastrointestinal, Liver, and Pancreatic Diseases in the United States: Update 2018. Gastroenterology. 2019 Jan;156(1):254-272.e11. doi: 10.1053/j.gastro.2018.08.063. Epub 2018 Oct 10.
PubMed 30315778Riezzo G, Russo F, Indrio F. Electrogastrography in adults and children: the strength, pitfalls, and clinical significance of the cutaneous recording of the gastric electrical activity. Biomed Res Int. 2013;2013:282757. doi: 10.1155/2013/282757. Epub 2013 May 25.
PubMed 23762836Sperber AD, Bangdiwala SI, Drossman DA, Ghoshal UC, Simren M, Tack J, Whitehead WE, Dumitrascu DL, Fang X, Fukudo S, Kellow J, Okeke E, Quigley EMM, Schmulson M, Whorwell P, Archampong T, Adibi P, Andresen V, Benninga MA, Bonaz B, Bor S, Fernandez LB, Choi SC, Corazziari ES, Francisconi C, Hani A, Lazebnik L, Lee YY, Mulak A, Rahman MM, Santos J, Setshedi M, Syam AF, Vanner S, Wong RK, Lopez-Colombo A, Costa V, Dickman R, Kanazawa M, Keshteli AH, Khatun R, Maleki I, Poitras P, Pratap N, Stefanyuk O, Thomson S, Zeevenhooven J, Palsson OS. Worldwide Prevalence and Burden of Functional Gastrointestinal Disorders, Results of Rome Foundation Global Study. Gastroenterology. 2021 Jan;160(1):99-114.e3. doi: 10.1053/j.gastro.2020.04.014. Epub 2020 Apr 12.
PubMed 32294476Gharibans AA, Coleman TP, Mousa H, Kunkel DC. Spatial Patterns From High-Resolution Electrogastrography Correlate With Severity of Symptoms in Patients With Functional Dyspepsia and Gastroparesis. Clin Gastroenterol Hepatol. 2019 Dec;17(13):2668-2677. doi: 10.1016/j.cgh.2019.04.039. Epub 2019 Apr 19.
PubMed 31009794
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastro-intestinal Biopotential Recorder by Means of Surface ELEctrodes
- ClinicalTrials.gov ID
- NCT06197334
- Acronym / sponsor ID
- GRELE / 2023-A01618-37
- Keywords
- Medical device, Electrophysiology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 9 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Experimental | Device: Gastro-intestinal biopotentials recording |
| Crohn's disease patients with fibrosis | Experimental | Device: Gastro-intestinal biopotentials recording |
| Crohn's disease patients without fibrosis | Experimental | Device: Gastro-intestinal biopotentials recording |
| Functional gastrointestinal disorders patients | Experimental | Device: Gastro-intestinal biopotentials recording |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastro-intestinal biopotentials recordingParticipants 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. | Device | Crohn's disease patients with fibrosis, Crohn's disease patients without fibrosis, Functional gastrointestinal disorders patients, Healthy volunteers |
Primary outcome
Gastro-intestinal biopotentials pattern as recorded by the homemade recorder
Time frame: 12 months
Gastro-intestinal biopotentials pattern in patients versus healthy volunteers
5 secondary outcomes
Correlation score between gastro-intestinal biopotentials pattern as recorded by the homemade recorder vs Harvey-Bradshaw Index assessed with a questionnaire
Time frame: 12 months
Correlation score between gastro-intestinal biopotentials pattern as recorded by the homemade recorder vs the Nancy score assessed by a clinician rating MRI images
Time frame: 12 months
Correlation score between gastro-intestinal biopotentials pattern as recorded by the homemade recorder vs blood fecal calprotectin levels (µg/g)
Time frame: 12 months
Correlation score between gastro-intestinal biopotentials pattern as recorded by the homemade recorder vs C-reactive protein levels (µg/L)
Time frame: 12 months
Correlation score between gastro-intestinal biopotentials pattern as recorded by the homemade recorder vs Rome IV criteria
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Background: PubMed 33656985Alighaleh S, Cheng L, Angeli-Gordon TR, Aghababaie Z, O'Grady G, Paskaranandavadivel N. Design and Validation of a Surface-Contact Electrode for Gastric Pacing and Concurrent Slow-Wave Mapping. IEEE Trans Biomed Eng. 2021 Aug;68(8):2574-2581. doi: 10.1109/TBME.2021.3063685. Epub 2021 Jul 16.
- Background: PubMed 33063188Axelrod L, Axelrod S, Navalgund A, Triadafilopoulos G. Pilot Validation of a New Wireless Patch System as an Ambulatory, Noninvasive Tool That Measures Gut Myoelectrical Signals: Physiologic and Disease Correlations. Dig Dis Sci. 2021 Oct;66(10):3505-3515. doi: 10.1007/s10620-020-06663-y. Epub 2020 Oct 15.
- Background: PubMed 24415856Bassotti G, Antonelli E, Villanacci V, Salemme M, Coppola M, Annese V. Gastrointestinal motility disorders in inflammatory bowel diseases. World J Gastroenterol. 2014 Jan 7;20(1):37-44. doi: 10.3748/wjg.v20.i1.37.
- Background: PubMed 35916432Calder S, Cheng LK, Andrews CN, Paskaranandavadivel N, Waite S, Alighaleh S, Erickson JC, Gharibans A, O'Grady G, Du P. Validation of noninvasive body-surface gastric mapping for detecting gastric slow-wave spatiotemporal features by simultaneous serosal mapping in porcine. Am J Physiol Gastrointest Liver Physiol. 2022 Oct 1;323(4):G295-G305. doi: 10.1152/ajpgi.00049.2022. Epub 2022 Aug 2.
- Background: PubMed 31535980Erickson JC, Bruce LE, Taylor A, Richman J, Higgins C, Wells CI, O'Grady G. Electrocolonography: Non-Invasive Detection of Colonic Cyclic Motor Activity From Multielectrode Body Surface Recordings. IEEE Trans Biomed Eng. 2020 Jun;67(6):1628-1637. doi: 10.1109/TBME.2019.2941851. Epub 2019 Sep 16.
- Background: PubMed 35699340Gharibans AA, Hayes TCL, Carson DA, Calder S, Varghese C, Du P, Yarmut Y, Waite S, Keane C, Woodhead JST, Andrews CN, O'Grady G. A novel scalable electrode array and system for non-invasively assessing gastric function using flexible electronics. Neurogastroenterol Motil. 2023 Feb;35(2):e14418. doi: 10.1111/nmo.14418. Epub 2022 Jun 14.
- Background: PubMed 18988693Huizinga JD, Lammers WJ. Gut peristalsis is governed by a multitude of cooperating mechanisms. Am J Physiol Gastrointest Liver Physiol. 2009 Jan;296(1):G1-8. doi: 10.1152/ajpgi.90380.2008. Epub 2008 Nov 6.
- BackgroundKhan, M.U., Aziz, S., Sohail, M., Shahid, A.A., Samer, S., 2019. Automated Detection and Classification of Gastrointestinal Diseases using surface-EMG Signals, in: 2019 22nd International Multitopic Conference (INMIC). IEEE, pp. 1-8. https://doi.org/10.1109/INMIC48123.2019.9022741
- BackgroundNavalgund, A., Axelrod, S., Triadafilopoulos, G., 2015. Feasibility of measuring the contractile electrical complex over 72 hours in a healthy human subject using a wearable, wireless electrode patch.
- Background: PubMed 29050646Ng SC, Shi HY, Hamidi N, Underwood FE, Tang W, Benchimol EI, Panaccione R, Ghosh S, Wu JCY, Chan FKL, Sung JJY, Kaplan GG. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. Lancet. 2017 Dec 23;390(10114):2769-2778. doi: 10.1016/S0140-6736(17)32448-0. Epub 2017 Oct 16.
- Background: PubMed 30315778Peery AF, Crockett SD, Murphy CC, Lund JL, Dellon ES, Williams JL, Jensen ET, Shaheen NJ, Barritt AS, Lieber SR, Kochar B, Barnes EL, Fan YC, Pate V, Galanko J, Baron TH, Sandler RS. Burden and Cost of Gastrointestinal, Liver, and Pancreatic Diseases in the United States: Update 2018. Gastroenterology. 2019 Jan;156(1):254-272.e11. doi: 10.1053/j.gastro.2018.08.063. Epub 2018 Oct 10.
- Background: PubMed 23762836Riezzo G, Russo F, Indrio F. Electrogastrography in adults and children: the strength, pitfalls, and clinical significance of the cutaneous recording of the gastric electrical activity. Biomed Res Int. 2013;2013:282757. doi: 10.1155/2013/282757. Epub 2013 May 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastro-intestinal biopotentials recording in people with Crohn Disease and Functional Gastrointestinal Disorders, run by Central Hospital, Nancy, France at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastro-intestinal biopotentials pattern as recorded by the homemade recorder (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06197334, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.