Crohn DiseaseGutcheck-CDNCT03774485
Myoelectric GutPrint-Crohn's Disease
An observational study of Crohn Disease, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn Disease
- What is being tested?
- G-Tech Gutcheck Myoelectric recording device
- Type of treatment
- Medical device
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 15 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- Patients with Crohn's disease and healthy subjects above the age of 18 who are able to give consent and follow direction.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Study of Myoelectric GutPrint of Healthy Controls and Crohn's Disease Patients During Flare and Remission
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.
Read the detailed description
Crohn's disease (CD) patients can have a chronic, relapsing course with frequent flares despite aggressive therapy. Flares are often difficult to predict. The goal of disease monitoring is to identify patients at risk for flare in order to treat earlier, with the hope of maintaining remission and avoiding irreversible bowel damage such as fistulas and strictures that may lead to surgery. Although endoscopic visualization of the mucosa allows in some cases ability to predict flare and determine deep remission, this procedure is invasive and requires anesthesia and a bowel preparation, and is not without risk. Abdominal pain, cramps and diarrhea are particularly common symptoms of CD, which are associated with alteration of gastrointestinal (GI) motility. Thus better understanding of GI motility patterns in CD flare and remission states may be helpful for prediction of flare for guiding appropriate therapy.
The goal of this study is to determine whether the motility patterns measured by the G-Tech non-invasive, wireless patch system can provide useful insight for routine CD care. Three G-Tech patches will be placed on the patients' abdomen and they will be given an iPod Touch to carry with them for the next 3-6 days. Data from the patches is processed offline to obtain motility patterns of the stomach, small intestine and colon. These patterns represent a rich trove of data that can be studied in multiple ways to provide comparisons and insight. Some examples are the overall strength of motor activity in each of the organs, the duration and rhythmicity, the correlation with meals, pain events and bowel movements, day to day variations and their correlation with symptoms, and diurnal effects.
- Conditions
- Crohn Disease
- Being tested
- G-Tech Gutcheck Myoelectric recording device
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-Tech Gutcheck Myoelectric recording deviceDevice
Also called Gastro-intestinal electrical recording
Three G-Tech patches are placed on the abdomen of the patient to record myoelectric activity.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: G-Tech Gutcheck Myoelectric recording device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myoelectric activity pattern (physiological parameters)
Myoelectric activity pattern in Crohn's disease patients versus healthy controls
Measured: change from baseline at 1 month, 3 months and 6 months after recruitment
Secondary outcomes (2)
Number of anticipated Adverse Events
Device related anticipated adverse events; such as, skin irritation due to adhesive from the skin patch.
Measured: Up to 6 days
Number of unanticipated adverse device effects
Unanticipated adverse device effects
Measured: Up to 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start1 Jan 2019
- Primary completion31 Mar 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)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 Stanford UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust, G-Tech Corporation
- Responsible party
- Principal investigator, Sidhartha Ranjit Sinha, Stanford University
- Investigators
- Sidhartha Sinha, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774485
- Sponsor's protocol ID
- IRB48539
- Acronym
- Gutcheck-CD
- Status last verified
- Oct 2023
- First submitted
- 29 Nov 2018
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will share the data through publication of results. Individual participant data was not promised to be shared.
Publications
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.
PubMed 30048596Navalgund 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.
PubMed 30390183Xavier RJ, Podolsky DK. Unravelling the pathogenesis of inflammatory bowel disease. Nature. 2007 Jul 26;448(7152):427-34. doi: 10.1038/nature06005.
PubMed 17653185Schoepfer 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.
PubMed 17924558Abdalla 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.
PubMed 28092305Barratt 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.
PubMed 21695401Grover 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.
PubMed 18848909von 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.
PubMed 18466904Minderhoud 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.
PubMed 15139501Bickelhaupt 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.
PubMed 23495824Bickelhaupt 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.
PubMed 23973163
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study of Myoelectric GutPrint of Healthy Controls and Crohn's Disease Patients During Flare and Remission
- ClinicalTrials.gov ID
- NCT03774485
- Acronym / sponsor ID
- Gutcheck-CD / IRB48539
- Conditions
- Crohn Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust, G-Tech Corporation
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 13 Dec 2018 (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.
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.
Detailed description
Crohn's disease (CD) patients can have a chronic, relapsing course with frequent flares despite aggressive therapy. Flares are often difficult to predict. The goal of disease monitoring is to identify patients at risk for flare in order to treat earlier, with the hope of maintaining remission and avoiding irreversible bowel damage such as fistulas and strictures that may lead to surgery. Although endoscopic visualization of the mucosa allows in some cases ability to predict flare and determine deep remission, this procedure is invasive and requires anesthesia and a bowel preparation, and is not without risk. Abdominal pain, cramps and diarrhea are particularly common symptoms of CD, which are associated with alteration of gastrointestinal (GI) motility. Thus better understanding of GI motility patterns in CD flare and remission states may be helpful for prediction of flare for guiding appropriate therapy.
The goal of this study is to determine whether the motility patterns measured by the G-Tech non-invasive, wireless patch system can provide useful insight for routine CD care. Three G-Tech patches will be placed on the patients' abdomen and they will be given an iPod Touch to carry with them for the next 3-6 days. Data from the patches is processed offline to obtain motility patterns of the stomach, small intestine and colon. These patterns represent a rich trove of data that can be studied in multiple ways to provide comparisons and insight. Some examples are the overall strength of motor activity in each of the organs, the duration and rhythmicity, the correlation with meals, pain events and bowel movements, day to day variations and their correlation with symptoms, and diurnal effects.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | Device: G-Tech Gutcheck Myoelectric recording deviceRecord gastrointestinal motility by G-Tech Gutcheck Myoelectric recording device in healthy controls. The investigator does not change the routine medical care of study participants. |
| Crohn's disease (remission state) | – | Device: G-Tech Gutcheck Myoelectric recording deviceRecord 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. |
| Crohn's disease (flare state) | – | Device: G-Tech Gutcheck Myoelectric recording deviceRecord 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- Patients with Crohn's disease and healthy subjects above the age of 18 who are able to give consent and follow direction.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| G-Tech Gutcheck Myoelectric recording deviceAlso: Gastro-intestinal electrical recordingThree G-Tech patches are placed on the abdomen of the patient to record myoelectric activity. | Device | Crohn's disease (flare state), Crohn's disease (remission state), Healthy controls |
Primary outcome
Myoelectric activity pattern (physiological parameters)
Time frame: change from baseline at 1 month, 3 months and 6 months after recruitment
Myoelectric activity pattern in Crohn's disease patients versus healthy controls
2 secondary outcomes
Number of anticipated Adverse Events
Time frame: Up to 6 days
Number of unanticipated adverse device effects
Time frame: Up to 6 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Background: PubMed 30048596Dua 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.
- Background: PubMed 30390183Navalgund 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.
- Background: PubMed 17653185Xavier RJ, Podolsky DK. Unravelling the pathogenesis of inflammatory bowel disease. Nature. 2007 Jul 26;448(7152):427-34. doi: 10.1038/nature06005.
- Background: PubMed 17924558Schoepfer 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.
- Background: PubMed 28092305Abdalla 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.
- Background: PubMed 21695401Barratt 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.
- Background: PubMed 18848909Grover 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.
- Background: PubMed 18466904von 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.
- Background: PubMed 15139501Minderhoud 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.
- Background: PubMed 23495824Bickelhaupt 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.
- Background: PubMed 23973163Bickelhaupt 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.
- Individual participant dataSharing planned: No. We will share the data through publication of results. Individual participant data was not promised to be shared.
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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. This study is not recruiting at the moment.
Sidhartha Sinha, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease, run by Stanford University at 1 site in United States.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myoelectric activity pattern (physiological parameters) (time frame: change from baseline at 1 month, 3 months and 6 months after recruitment). 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 NCT03774485, which also lists 11 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 6 Oct 2023.