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The goal of this observational study is to identify factors that influence symptoms in children with irritable bowel syndrome (IBS), to find ways to make diet treatments work better and possibly create personalized plans to help each child with IBS feel better. The main question it aims to answer is:
Participants will use the wearable patch, answer questionnaires, collect stool and urine samples, and recall their 24 hours dietary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBS Cohort | Participants ages 8 to 18 years old who meet Rome IV diagnostic criteria for IBS |
| |
| Control Cohort | Participants ageds 8-18 years old who don't have IBS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wireless Patch System | Diagnostic Test | The Wireless Patch System will be placed on the abdominal skin. Participants will receive an iPhone containing the WPS app to record symptoms and meals. Participants undergoing a clinically indicated dietary intervention will complete study procedures before and after the dietary intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Gut myoelectric activity in children with IBS and controls using the non-invasive wireless patch system (WPS) | Differences in total activity, pre- and post-prandial activity ratios, nighttime colonic activity, and night-to-day colonic activity ratios between IBS patients and controls. WPS reading will be completed after each study visit. Differences will be compared at the 3rd and 4th quarters of each year. | Approximately one year. |
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Inclusion Criteria:
Cases:
Controls:
Exclusion Criteria:
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Controls:
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Participants meet the eligibility criteria listed.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alain Benitez, MD, MSTR | Contact | 215-590-1000 | BenitezA@chop.edu |
| Name | Affiliation | Role |
|---|---|---|
| Alain Benitez, MD, MSTR | Children's Hospital of Philadelphia, University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33063188 | 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. |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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Urine Stool
|
| D004066 | Digestive System Diseases |