Trials / Recruiting
RecruitingNCT05633706
Evaluation of the SIMBA Capsule for Small Intestinal Dysbiosis
Evaluation of the Small Intestine Microbiome Aspiration (SIMBA) Capsule for Small Intestinal Dysbiosis
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (estimated)
- Sponsor
- Nimble Science Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
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.
Conditions
- Irritable Bowel Syndrome
- Crohn Disease
- Celiac Disease
- Ulcerative Colitis
- Functional Dyspepsia
- Type 2 Diabetes
- Healthy
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | fluid biopsy capsule | Collection of a fluid biopsy from the small intestine via ingestible capsule |
Timeline
- Start date
- 2023-01-09
- Primary completion
- 2025-06-06
- Completion
- 2025-06-06
- First posted
- 2022-12-01
- Last updated
- 2025-04-15
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT05633706. Inclusion in this directory is not an endorsement.