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| Name | Class |
|---|---|
| Nimble Science Ltd. | INDUSTRY |
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Prospective, open label trial to establish the ability of the SIMBA Capsule to accurately obtain a sample from the small bowel of participants with IBS (10 constipation-predominant (IBS-C) and 10 diarrhea-predominant (IBS-D)) and healthy participants (n=10). The accuracy of targeting the small bowel will be established by visual confirmation via X-ray. The clinical utility of the collected sample will be evaluated by analysis with samples obtained by the current gold standard (duodenal aspirate), as well as stool analysis and LBT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBS-D | Active Comparator | Participant diagnosed with Irritable Bowel Syndrome, diarrhea predominant, confirmed by study doctors using Rome IV criteria. |
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| IBS-C | Active Comparator | Participant diagnosed with Irritable Bowel Syndrome, constipation predominant, confirmed by study doctors using Rome IV criteria. |
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| Healthy Control | Active Comparator | Participant with no ongoing medical conditions affecting GI health. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ingestible capsule | Device | Participants will swallow capsules and collect in stool concurrent with stool samples |
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| Measure | Description | Time Frame |
|---|---|---|
| Bacterial composition | 1. Correlations of bacterial composition (superimposability of PLS-DA mapping) of samples collected by the SIMBA Capsule compared to small bowel aspirate and to mucosal microbiome sample obtained by brushing. (hypothesis: findings will be similar) | same day |
| Bacterial composition | 2. Correlations of bacterial composition (superimposability of PLS-DA mapping) of samples collected by the SIMBA Capsule compared to stool sample obtained at same time. (hypothesis: findings will be different) | same day |
| Measure | Description | Time Frame |
|---|---|---|
| Bacterial composition | 1. Correlation of hydrogen- and methane-producing bacteria species (by 16s RNA sequencing) found by SIMBA Capsule with hydrogen and methane concentrations (peak and rise in ppm) detected by LBT and bacterial density (CFU/ml) of endoscopic aspirate. | within 5 days of primary measures |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Christopher N Andrews | Cumming School of Medicine, University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cumming School of Medicine, University of Calgary | Calgary | Alberta | T2N 4Z6 | Canada |
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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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| Sedated EGD | Procedure | Participants will undergo sedated esophagogastroduodenoscopy (EGD) for collection of small intestine aspirate and simultaneous saliva sample. |
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| Lactulose Breath Test | Diagnostic Test | Hydrogen and methane breath test with lactulose substrate |
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| D004066 | Digestive System Diseases |