Actively Recruiting
Evaluation of the SIMBA Capsule for Small Intestinal Dysbiosis
Led by Nimble Science Ltd. · Updated on 2025-04-15
300
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
Sponsors
N
Nimble Science Ltd.
Lead Sponsor
M
Mitacs
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of the SIMBA Capsule for Small Intestinal Dysbiosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 80 years.
- For the control group, no previous diagnosis of Celiac Disease, Ulcerative Colitis, Crohn's disease, IBS, Functional Dyspepsia, or Type 2 Diabetes by self-report.
- For the disease group, prior diagnosis of Celiac Disease, Ulcerative Colitis, Crohn's disease, IBS, Functional Dyspepsia, or Type 2 Diabetes confirmed by a health professional or consultation with the investigator.
- Ability to understand and provide informed consent.
- Ability and willingness to meet the study schedule, interventions, and complete questionnaires.
- No planned changes in diet or medical treatments during the study.
- For the control group, having at least 2 bowel movements per week.
You will not qualify if you...
- Known diseases that may cause intestinal narrowing or blockage risking capsule retention, including achalasia, eosinophilic esophagitis, recent cancer diagnosis or treatment, or prior gastrointestinal surgeries except appendectomy or cholecystectomy more than 3 months ago.
- History of obstructive symptoms within 3 months before enrollment.
- Use of medications or procedures in the past week that could alter gastrointestinal movement, including opioids, anticholinergics, or certain laxatives.
- Disallowed laxatives within 7 days before capsule ingestion include osmotic laxatives, stool softeners, and secretagogues.
- Allowed stimulant laxatives and prokinetics only if usage is stable in the week before capsule ingestion.
- Must be able to stop PPI or H2RA medications 48 hours before capsule ingestion and may resume 4 hours after.
- History of swallowing disorders with risk of capsule aspiration.
- Known structural gastrointestinal abnormalities causing mechanical obstruction.
- History of abdominal radiation treatment.
- Females who are pregnant or breastfeeding.
- Use of antibiotics or bowel cleanses within 2 weeks before the study.
- For control group, fewer than 2 bowel movements per week.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Nimble Science
Calgary, Alberta, Canada, T2P 3P2
Actively Recruiting
Research Team
G
Gwen Duytschaever, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
7
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