Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Mitacs | INDUSTRY |
| University of Calgary | OTHER |
Not provided
Not provided
Not provided
The SIMBA Capsule is a small, single-use, ingestible capsule that allows for the non-invasive sampling of small bowel contents using purely mechanical means. The study will compare the microbial and metabolomics analysis from the sample collected with the capsule series, to same-participant symptom questionnaires and stool microbial analysis.
The investigators primary goal is to assess the correlation of gut symptoms from various disease states with the dysbiosis of the small intestinal microbiome and metabolites collected by the SIMBA capsule, and as identified and measured by metagenomic sequencing and/or metabolomics approaches. The process consists of ingestion and collection of up to 4 SIMBA capsules, on up to 2 separate occasions, along with collection of a stool sample at the same time. Participants will also fill out a series of questionnaires on medical history and lifestyle inputs (eg. diet, exercise, mental health) GI symptoms, anxiety, and depression. The investigators ultimate goal will be to develop a better understanding of how the small intestinal microbiome might play a role in symptom generation, to establish whether the SIMBA capsule can find a signature of dysbiosis which can be used as a biomarker for a number of functional gut disorders.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy | Not belonging to the other cohorts as described below. |
| |
| Irritable Bowel Syndrome | As confirmed by diagnosis and/or PI assessment, and measured via patient response to validated questionnaires - no interventions applied. |
| |
| Crohns Disease | As confirmed by diagnosis and/or PI assessment, and measured via patient response to validated questionnaires - no interventions applied. |
| |
| Ulcerative Colitis | As confirmed by diagnosis and/or PI assessment, and measured via patient response to validated questionnaires - no interventions applied. |
| |
| Celiac Disease | As confirmed by diagnosis and/or PI assessment, and measured via patient response to validated questionnaires - no interventions applied. |
| |
| Functional Dyspepsia |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluid biopsy capsule | Device | Collection of a fluid biopsy from the small intestine via ingestible capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of bacterial composition with gastrointestinal disease states as assessed by PLS-DA mapping. | The bacterial composition of healthy control fluid biopsy is compared to the bacterial composition of participants with diagnosed gastrointestinal diseases, to aid in gastrointestinal disease biomarker discovery. | baseline, pre-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of bacterial composition with dietary intake as assessed by PLS-DA mapping. | Fluid biopsy bacterial composition correlated with self-reported long-term and short-term preferred variations in intake of dietary fiber and organic food. | baseline, pre-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Usability of SIMBA capsule in various disease states as assessed by SIMBA-experience questionnaires. | Participant feedback on SIMBA capsule usage experience will inform usability data. | immediately after the procedure |
| Comparison of SIMBA fluid biopsy microbial composition to stool microbial composition as assessed by 16s rRNA metagenomic analysis. |
Inclusion Criteria:
Exclusion Criteria
Known disease which, in the investigator's opinion, would lead to intestinal structuring or obstruction with a risk of capsule non-excretion (particular diseases which would be assessed on a case-by-case basis would include, achalasia, eosinophilic esophagitis, cancer diagnosis or treatment within the past year, or previous esophageal, gastric, small intestinal, or colonic surgery. Appendectomy or cholecystectomy more than 3 months prior to enrollment are acceptable). The main deciding factor would be a history of obstructive symptoms in the previous 3 months prior to entry.
Use of any medications or having undergone procedures in the previous week that could substantially alter gastrointestinal motor function (e.g., opioids, anticholinergics, laxatives, or GLP-1 analogues).
History of oropharyngeal dysphagia or other swallowing disorder with a risk of aspiration of the capsule.
History of known structural gastrointestinal abnormalities such as strictures or fistulas leading to mechanical obstruction
History of abdominal radiation treatment
Females of childbearing age who are pregnant or lactating by self-report. (should an X-ray be required for confirmation of capsule passage, a urine pregnancy test will be administered beforehand).
No antibiotics, or colon cleanses/bowel prep for 2 weeks.
< 2 bowel movements per week (Control Group only).
Not provided
Not provided
Up to 300 individuals, females or males will be enrolled in this study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gwen Duytschaever, PhD | Contact | 8664934633 | clinical@nimblesci.com |
| Name | Affiliation | Role |
|---|---|---|
| Chris Andrews, MD | Nimble Science Ltd. | Principal Investigator |
| Matthew Woo, MD | Nimble Science Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nimble Science | Recruiting | Calgary | Alberta | T2P 3P2 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D003424 | Crohn Disease |
| D002446 | Celiac Disease |
| D003093 | Colitis, Ulcerative |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Fluid from the small intestine, stool, saliva
As confirmed by diagnosis and/or PI assessment, and measured via patient response to validated questionnaires - no interventions applied.
|
| Type 2 Diabetes | As confirmed by diagnosis and/or PI assessment, and measured via patient response to validated questionnaires - no interventions applied. |
|
| baseline, pre-procedure |
| Correlations of bacterial composition with anxiety (GAD-7) scores as assessed by PCoA mapping, alpha and beta diversity analysis. | baseline, pre-procedure |
| Correlations of bacterial composition with depression (PHQ-8) scores as assessed by PCoA mapping, alpha and beta diversity analysis. | baseline, pre-procedure |
| Correlations of bacterial composition with self-reported lifestyle behaviours as assessed by PCoA mapping, alpha and beta diversity analysis. | baseline, pre-procedure |
| Number of participants with device-related adverse events as assessed by an independent Data Safety Monitoring Board. | through study completion, an average of 8 days |
| Evaluate the usability of excreted SIMBA Capsule retrieval procedures as assessed by retrieval-experience questionnaire feedback. | immediately after the procedure |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D008286 | Malabsorption Syndromes |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003092 | Colitis |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |