Myoelectric GutPrint-Crohn's Disease

NCT03774485 | Completed

• 1 other identifier: IRB48539
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

A feasibility study for assessing and recording myoelectric activity in patients for early detection of flare in patients with Crohn's disease and differentiating the myoelectric signals from Crohn's disease patients in remission state and healthy controls.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• Myoelectric activity pattern (physiological parameters)

  Myoelectric activity pattern in Crohn's disease patients versus healthy controls

  change from baseline at 1 month, 3 months and 6 months after recruitment

Secondary Outcomes (2)

• Number of anticipated Adverse Events

  Up to 6 days

• Number of unanticipated adverse device effects

  Up to 6 days

Study Arms (3)

Healthy controls

Record gastrointestinal motility by G-Tech Gutcheck Myoelectric recording device in healthy controls. The investigator does not change the routine medical care of study participants.

Device: G-Tech Gutcheck Myoelectric recording device

Crohn's disease (remission state)

Record gastrointestinal motility by G-Tech Gutcheck Myoelectric recording device in subjects with Crohn's disease (remission state). The investigator does not change the routine medical care of study participants.

Device: G-Tech Gutcheck Myoelectric recording device

Crohn's disease (flare state)

Record gastrointestinal motility by G-Tech Gutcheck Myoelectric recording device in subjects with Crohn's disease (flare state). The investigator does not change the routine medical care of study participants.

Device: G-Tech Gutcheck Myoelectric recording device

Interventions

G-Tech Gutcheck Myoelectric recording device DEVICE

Three G-Tech patches are placed on the abdomen of the patient to record myoelectric activity.

Also known as: Gastro-intestinal electrical recording

Crohn's disease (flare state); Crohn's disease (remission state); Healthy controls

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy subjects without gastrointestinal symptoms or history of gastrointestinal surgeries. Patients with Crohn's disease in remission state or flare state (exclude severe Crohn's disease due to complexity of disease, complication, and potential needs for surgery; on new medications 【e.g. within 3 months of enrollment】 known to alter GI motility or bowel surgeries due to potential impact on the G-Tech results)

You may qualify if:

• Patients with Crohn's disease and healthy subjects above the age of 18 who are able to give consent and follow direction.

You may not qualify if:

• Patients or subjects under the age of 18, pregnant, and those unable to give consent or follow direction.
• Healthy subjects with gastrointestinal symptoms or history of gastrointestinal surgeries.
• Patients with severe Crohn's disease due to complexity of disease, complication, and potential needs for surgery.
• Patients with bowel surgeries due to potential impact on the G-Tech results. For similar reasons we will exclude patients on new medications (e.g. within 3 months of enrollment) known to alter GI motility but we will not exclude patients on stable doses or chronic GI motility agents as this mimics "real world" in which the G-Tech patch will be used and we can learn the stability of the motility recordings over time in stable patients.

Sponsors & Collaborators

• Stanford University: lead
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator
• G-Tech Corporation: collaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

Location

Related Publications (11)

• Dua MM, Navalgund A, Axelrod S, Axelrod L, Worth PJ, Norton JA, Poultsides GA, Triadafilopoulos G, Visser BC. Monitoring gastric myoelectric activity after pancreaticoduodenectomy for diet "readiness". Am J Physiol Gastrointest Liver Physiol. 2018 Nov 1;315(5):G743-G751. doi: 10.1152/ajpgi.00074.2018. Epub 2018 Jul 26.

  PMID: 30048596 BACKGROUND

• Navalgund A, Axelrod S, Axelrod L, Singhal S, Tran K, Legha P, Triadafilopoulos G. Colon Myoelectric Activity Measured After Open Abdominal Surgery with a Noninvasive Wireless Patch System Predicts Time to First Flatus. J Gastrointest Surg. 2019 May;23(5):982-989. doi: 10.1007/s11605-018-4030-4. Epub 2018 Nov 2.

  PMID: 30390183 BACKGROUND

• Xavier RJ, Podolsky DK. Unravelling the pathogenesis of inflammatory bowel disease. Nature. 2007 Jul 26;448(7152):427-34. doi: 10.1038/nature06005.

  PMID: 17653185 BACKGROUND

• Schoepfer AM, Trummler M, Seeholzer P, Seibold-Schmid B, Seibold F. Discriminating IBD from IBS: comparison of the test performance of fecal markers, blood leukocytes, CRP, and IBD antibodies. Inflamm Bowel Dis. 2008 Jan;14(1):32-9. doi: 10.1002/ibd.20275.

  PMID: 17924558 BACKGROUND

• Abdalla MI, Sandler RS, Kappelman MD, Martin CF, Chen W, Anton K, Long MD. Prevalence and Impact of Inflammatory Bowel Disease-Irritable Bowel Syndrome on Patient-reported Outcomes in CCFA Partners. Inflamm Bowel Dis. 2017 Feb;23(2):325-331. doi: 10.1097/MIB.0000000000001017.

  PMID: 28092305 BACKGROUND

• Barratt SM, Leeds JS, Robinson K, Lobo AJ, McAlindon ME, Sanders DS. Prodromal irritable bowel syndrome may be responsible for delays in diagnosis in patients presenting with unrecognized Crohn's disease and celiac disease, but not ulcerative colitis. Dig Dis Sci. 2011 Nov;56(11):3270-5. doi: 10.1007/s10620-011-1783-y. Epub 2011 Jun 22.

  PMID: 21695401 BACKGROUND

• Grover M, Herfarth H, Drossman DA. The functional-organic dichotomy: postinfectious irritable bowel syndrome and inflammatory bowel disease-irritable bowel syndrome. Clin Gastroenterol Hepatol. 2009 Jan;7(1):48-53. doi: 10.1016/j.cgh.2008.08.032. Epub 2008 Sep 3.

  PMID: 18848909 BACKGROUND

• von Stein P, Lofberg R, Kuznetsov NV, Gielen AW, Persson JO, Sundberg R, Hellstrom K, Eriksson A, Befrits R, Ost A, von Stein OD. Multigene analysis can discriminate between ulcerative colitis, Crohn's disease, and irritable bowel syndrome. Gastroenterology. 2008 Jun;134(7):1869-81; quiz 2153-4. doi: 10.1053/j.gastro.2008.02.083. Epub 2008 Mar 2.

  PMID: 18466904 BACKGROUND

• Minderhoud IM, Oldenburg B, Wismeijer JA, van Berge Henegouwen GP, Smout AJ. IBS-like symptoms in patients with inflammatory bowel disease in remission; relationships with quality of life and coping behavior. Dig Dis Sci. 2004 Mar;49(3):469-74. doi: 10.1023/b:ddas.0000020506.84248.f9.

  PMID: 15139501 BACKGROUND

• Bickelhaupt S, Pazahr S, Chuck N, Blume I, Froehlich JM, Cattin R, Raible S, Bouquet H, Bill U, Rogler G, Frei P, Boss A, Patak MA. Crohn's disease: small bowel motility impairment correlates with inflammatory-related markers C-reactive protein and calprotectin. Neurogastroenterol Motil. 2013 Jun;25(6):467-73. doi: 10.1111/nmo.12088. Epub 2013 Mar 18.

  PMID: 23495824 BACKGROUND

• Bickelhaupt S, Froehlich JM, Cattin R, Patuto N, Tutuian R, Wentz KU, Culmann JL, Raible S, Bouquet H, Bill U, Patak MA. Differentiation between active and chronic Crohn's disease using MRI small-bowel motility examinations - initial experience. Clin Radiol. 2013 Dec;68(12):1247-53. doi: 10.1016/j.crad.2013.06.024. Epub 2013 Aug 21.

  PMID: 23973163 BACKGROUND

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Sidhartha Sinha, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: December 13, 2018
• Study Start: January 1, 2019
• Primary Completion: March 31, 2023
• Study Completion: June 15, 2023
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)