Validation of the Small Intestine Microbiome Aspiration (SIMBA) Capsule
- Conditions
- Proof of ConceptIrritable Bowel Syndrome
- Registration Number
- NCT04094558
- Lead Sponsor
- University of Calgary
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Bacterial composition same day 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)
- Secondary Outcome Measures
Name Time Method Bacterial composition within 5 days of primary measures 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.
Trial Locations
- Locations (1)
Cumming School of Medicine, University of Calgary
🇨🇦Calgary, Alberta, Canada
Cumming School of Medicine, University of Calgary🇨🇦Calgary, Alberta, Canada