Gastro-intestinal Biopotential Recorder by Means of Surface ELEctrodes

NCT06197334 | Recruiting

• 1 other identifier: 2023-A01618-37
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Crohn Disease; Functional Gastrointestinal Disorders; Healthy

Keywords

Medical device; Electrophysiology

Outcome Measures

Primary Outcomes (1)

• Gastro-intestinal biopotentials pattern as recorded by the homemade recorder

  Gastro-intestinal biopotentials pattern in patients versus healthy volunteers

  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

  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

  12 months

• Correlation score between gastro-intestinal biopotentials pattern as recorded by the homemade recorder vs blood fecal calprotectin levels (µg/g)

  12 months

• Correlation score between gastro-intestinal biopotentials pattern as recorded by the homemade recorder vs C-reactive protein levels (µg/L)

  12 months

• Correlation score between gastro-intestinal biopotentials pattern as recorded by the homemade recorder vs Rome IV criteria

  12 months

Study Arms (4)

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

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.

Crohn's disease patients with fibrosis; Crohn's disease patients without fibrosis; Functional gastrointestinal disorders patients; Healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (2)

CHRU Nancy

Vandœuvre-lès-Nancy, CHRU de Nancy, 54511, France

RECRUITING

CHRU de Nancy - Brabois

Vandœuvre-lès-Nancy, 54500, France

RECRUITING

Related Publications (14)

• 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.

  PMID: 33656985 BACKGROUND

• Axelrod 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.

  PMID: 33063188 BACKGROUND

• Bassotti 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.

  PMID: 24415856 BACKGROUND

• Calder 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.

  PMID: 35916432 BACKGROUND

• Erickson 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.

  PMID: 31535980 BACKGROUND

• Gharibans 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.

  PMID: 35699340 BACKGROUND

• Huizinga 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.

  PMID: 18988693 BACKGROUND

• Khan, 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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 29050646 BACKGROUND

• Peery 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.

  PMID: 30315778 BACKGROUND

• Riezzo 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.

  PMID: 23762836 BACKGROUND

• Sperber 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.

  PMID: 32294476 BACKGROUND

• Gharibans 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.

  PMID: 31009794 BACKGROUND

MeSH Terms

Conditions

Crohn Disease; Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 9, 2024
• Study Start: February 18, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)