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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
30
Participants will swallow capsules and collect in stool concurrent with stool samples
Participants will undergo sedated esophagogastroduodenoscopy (EGD) for collection of small intestine aspirate and simultaneous saliva sample.
Hydrogen and methane breath test with lactulose substrate
Cumming School of Medicine, University of Calgary
Calgary, Alberta, Canada
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)
Time frame: 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)
Time frame: same day
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.
Time frame: within 5 days of primary measures
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