Clinical trial NCT01026922: Use of an Ambulatory Capsule to Characterize Gastrointestinal Pressure Patterns in Children
Official title: Use of an Ambulatory Capsule to Characterize Gastrointestinal Pressure Patterns in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Upper Gastrointestinal Motility Disorders
Keywords: antroduodenal manometry
gastric dysmotility
intestinal dysmotility
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: The SmartPill Corporation
First posted: 2009-12-07
Enrollment: 22
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients coming to clinic for concerns of gastric or small bowel dysmotility

Brief summary: This study will test a new medical device called the SmartPill GI Monitoring System, which is now used to diagnose gastric motility disorders in adults, in children. The study will compare the SmartPill capsule findings to antroduodenal manometry (ADM), which is a standard procedure currently used for the evaluation of gastric and duodenal motility in children. The ADM studies will be done for clinical purposes and only if recommended by the patient's gastroenterologist. The research portion of the study is limited to the use of SmartPill.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: SmartPill use will be within 180 days of ADM
Secondary outcomes:
measure: The patient's tolerance using the Smartpill
timeFrame: The day the patient returns the SmartPill recording device
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Center for Digestive Disorders at Nationwide Childrens Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Carlo Di Lorenzo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.