- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01026922
Use of an Ambulatory Capsule to Characterize Gastrointestinal Pressure Patterns in Children
Study Overview
Status
Conditions
Detailed Description
ADM is a standard procedures used in children, but it has some limitations and disadvantages. Manometry studies involve placing catheters in the nose and are often poorly tolerated by children. Also, placement of the catheter requires sedation or anesthesia, the manometry test lasts several hours and involves ingestion of a meal which many children find difficult when having a catheter in their nose. The reason we are conducting this study is because we would like to find a new, less invasive, equally informative test for understanding gastrointestinal motility.
The SmartPill GI Monitoring System uses a capsule, about the size of a large vitamin or PillCam capsule, which is swallowed and passed through the stool. While in the GI tract, the capsule measures the acidity (pH) and pressures, and these measurements are used to determine how long it takes for food to leave the stomach. Pressure and pH information are sent by the capsule to a receiver that the patient will either wear on the belt or keep within 2 feet. The receiver stores data collected about the pH, temperature, and pressure inside the GI tract. The SmartPill GI Monitoring System has already been approved by the Food and Drug Administration (FDA) for use in adults but not in children.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ohio
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Columbus, Ohio, United States, 43205
- Center for Digestive Disorders at Nationwide Childrens Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children older than 10 years of age referred to our Motility Center to receive AD manometry studies will be offered participation to the study
- The patients will have to be able to swallow the SmartPill capsule
- The patients will need to have no evidence of strictures or narrowing
Exclusion Criteria:
- Inability to swallow the capsule
- Patients on TPN because of inability to tolerate enteral feedings (high likelihood of not emptying the capsule from the stomach)
- Children with evidence of strictures
- Children with history of esophageal or gastric surgeries, such as TE fistula, fundoplication, or gastrojejunostomy
- Children with a history of gastric bezoars
- Allergies to components of the test meal including eggs, bread, and jam
- Patients with history of inflammatory bowel disease
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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SmartPill Participants
It is a single-center study, children aged 8-17 years with severe upper GI symptoms (ie, nausea, vomiting, retching, abdominal pain) referred for antroduodenal manometry (ADM) studies underwent a wireless motility capsule (smartpill) test.
The scintigraphic gastric emptying study was done when clinically indicated either at the time of the ADM or at a different time within 1 year of the wireless motility capsule test.
In summary, we studied symptomatic adolescents using scintigraphic gastric emptying studies, ADM, and the wireless motility capsule test, with the goal of identifying the diagnostic yield of each test and exploring how they compare in detecting motor abnormalities in the GI tract.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Determine if a patient's gastric and duodenal motility is considered normal or abnormal, if their motility disorder considered as neuropathic (normal amplitude of contractions) or myopathic (low amplitude or absent contractions) based on ADM vs SmartPill
Time Frame: SmartPill use will be within 180 days of ADM
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Determine if a patient's gastric and duodenal motility is considered normal or abnormal, if their motility disorder considered as neuropathic (normal amplitude of contractions) or myopathic (low amplitude or absent contractions) based on ADM vs SmartPill.
The goal is to identify the diagnostic yield of each test and exploring how they compare in detecting motor abnormalities in the GI tract.
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SmartPill use will be within 180 days of ADM
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The patient's tolerance using the Smartpill
Time Frame: The day the patient returns the SmartPill recording device
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Assess the tolerability and safety of the wireless motility capsule test.
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The day the patient returns the SmartPill recording device
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Kuo B, McCallum RW, Koch KL, Sitrin MD, Wo JM, Chey WD, Hasler WL, Lackner JM, Katz LA, Semler JR, Wilding GE, Parkman HP. Comparison of gastric emptying of a nondigestible capsule to a radio-labelled meal in healthy and gastroparetic subjects. Aliment Pharmacol Ther. 2008 Jan 15;27(2):186-96. doi: 10.1111/j.1365-2036.2007.03564.x. Epub 2007 Oct 28.
- Cassilly D, Kantor S, Knight LC, Maurer AH, Fisher RS, Semler J, Parkman HP. Gastric emptying of a non-digestible solid: assessment with simultaneous SmartPill pH and pressure capsule, antroduodenal manometry, gastric emptying scintigraphy. Neurogastroenterol Motil. 2008 Apr;20(4):311-9. doi: 10.1111/j.1365-2982.2007.01061.x. Epub 2008 Jan 13.
- Rao SS, Kuo B, McCallum RW, Chey WD, DiBaise JK, Hasler WL, Koch KL, Lackner JM, Miller C, Saad R, Semler JR, Sitrin MD, Wilding GE, Parkman HP. Investigation of colonic and whole-gut transit with wireless motility capsule and radiopaque markers in constipation. Clin Gastroenterol Hepatol. 2009 May;7(5):537-44. doi: 10.1016/j.cgh.2009.01.017.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NCHSmartPill-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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