Actively Recruiting
Evaluation of the Small Intestine Microbiome Aspiration (SIMBA) Capsule for Small Intestinal Dysbiosis
Led by Nimble Science Ltd. · Updated on 2025-04-15
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
N
Nimble Science Ltd.
Lead Sponsor
M
Mitacs
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the SIMBA Capsule, a small, single-use, ingestible device designed to non-invasively collect samples from the small intestine using mechanical means. The study aims to understand how changes in the small intestinal microbiome and metabolites relate to gut symptoms across various diseases. This observational research seeks to identify potential biomarkers for functional gut disorders by comparing capsule-collected samples with stool microbial analysis and symptom questionnaires. Participants will swallow up to four SIMBA capsules on up to two separate occasions, providing small bowel fluid samples. Alongside this, stool samples will be collected simultaneously. No treatments are applied during the study, but participants will complete questionnaires about their medical history, lifestyle factors like diet and exercise, gastrointestinal symptoms, anxiety, and depression. The study includes groups with different gut-related conditions and healthy volunteers. During the study, participants will be assessed using metagenomic sequencing and metabolomics to analyze the bacterial composition and metabolites from the collected samples. Researchers will correlate these findings with gastrointestinal disease states and dietary intake. The study involves baseline assessments and pre-procedure evaluations, with the goal of better understanding symptom generation related to the small intestinal microbiome. Participation involves following study visits, sample collections, and completing questionnaires over the study duration.
CONDITIONS
Brief 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.
- No previous diagnosis of Celiac Disease, Ulcerative Colitis, Crohn's disease, IBS, Functional Dyspepsia, and Type 2 Diabetes by participant self-report (Control group).
- Prior diagnosis of Celiac Disease, Ulcerative Colitis, Crohn's disease, IBS, Functional Dyspepsia, or Type 2 Diabetes confirmed by relevant healthcare provider and willingness to provide documentation or consult with the principal investigator (Disease group).
- Ability to understand and provide informed consent.
- Ability and willingness to meet the required study schedule, interventions, and questionnaire requirements.
- No planned change in diet or medical interventions during the study duration.
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 major gastrointestinal surgery (except appendectomy or cholecystectomy more than 3 months ago).
- History of obstructive symptoms within 3 months before study entry.
- Use of medications or procedures within the past week that significantly affect gastrointestinal movement, such as opioids, anticholinergics, laxatives (except stable stimulant laxatives), or GLP-1 analogues.
- Inability to discontinue PPI or H2RA medications 48 hours before capsule ingestion.
- History of swallowing difficulties or risk of aspiration.
- Known structural gastrointestinal abnormalities causing obstruction.
- History of abdominal radiation treatment.
- Pregnancy or lactation in females of childbearing age.
- Use of antibiotics or colon cleanses/bowel preparation within the past 2 weeks.
- Fewer than 2 bowel movements per week (Control group only).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of capsule ingestion and sample collection visits as per participant schedule
Participants ingest up to 4 SIMBA capsules on up to 2 separate occasions for collection of small intestinal fluid biopsies. Stool samples are collected at the same time. Participants also complete questionnaires on medical history, lifestyle, gastrointestinal symptoms, anxiety, and depression.
Up to 2 visits for capsule ingestion and sample collection
Duration - Study duration until completion date June 6, 2025
Participants are observed to assess correlations between small intestinal microbiome composition and various gastrointestinal disease states, diet, and symptoms through analysis of collected samples and questionnaire data.
No additional visits required; observational follow-up
Trial Site Locations
Total: 1 location
1
Nimble Science
Calgary, Alberta, Canada, T2P 3P2
Actively Recruiting
Research Team
G
Gwen Duytschaever, PhD
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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