Irritable Bowel SyndromeNCT05633706
Evaluation of the SIMBA Capsule for Small Intestinal Dysbiosis
An observational study of Irritable Bowel Syndrome and Crohn Disease, run by Nimble Science Ltd. at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome, Crohn Disease, Celiac Disease
- What is being tested?
- fluid biopsy capsule
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 9 Jan 2023to Aug 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Up to 300 individuals, females or males will be enrolled in this study.
Who may be able to join
- 1. Aged between 18 and 80 years.
- No previous diagnosis of Celiac Disease, Ulcerative Colitis, Crohn's disease, IBS, Functional Dyspepsia, and T2D by participant self-report (Control group).
- Prior diagnosis of Celiac Disease, Ulcerative Colitis, Crohn's disease, IBS, or Functional Dyspepsia, and T2D by a relevant physician, nutritionist, naturopath, etc, and willingness to provide documentation to confirm this diagnosis or have a consultation with the PI. (Disease group).
- Ability to understand and provide informed consent.
- Ability and willingness to meet the required schedule, study interventions, and questionnaire requirements.
- No planned change in diet or medical interventions during the study duration.
Who cannot join
- 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).
- Stimulant laxative use (includes bisacodyl/Dulcolax, senna/Senekot, cascara, or fibre supplments) is allowed if it is kept unchanged in the week prior to the SIMBA Capsule ingestion. Osmotic laxatives (polyethylene glycol (PEG; other trade names), milk of magnesia, lactulose), stool softeners (docusate; other trade names) or secretagogues (linaclotide/Constella, plecanatide/Trulance, tenapanor/Ibsrela should not be used within 7 days of taking the SIMBA capsules.
- Prokinetics use is allowed if kept unchanged in the week prior to the SIMBA Capsule ingestion (includes domperidone, metoclopramide, prucalopride). Inconsistent use of prokinetics will be evaluated by the PI.
- PPI or H2RA use. Must be able to discontinue PPI or H2RA medications 48hrs prior to SIMBA capsule ingestion, medication can be resumed 4 hours after ingestion.
- History of oropharyngeal dysphagia or other swallowing disorder with a risk of aspiration of the capsule.
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Small Intestine Microbiome Aspiration (SIMBA) Capsule for Small Intestinal Dysbiosis
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.
Read the 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
- Being tested
- fluid biopsy capsule
- Keywords
- Microbiome
- Medical subject headings
- Irritable Bowel Syndrome, Crohn Disease, Celiac Disease, Colitis, Ulcerative, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluid biopsy capsuleDevice
Collection of a fluid biopsy from the small intestine via ingestible capsule
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Not belonging to the other cohorts as described below. Receives: Device: fluid biopsy capsule | |
| Irritable Bowel Syndrome | As confirmed by diagnosis and/or PI assessment, and measured via patient response to validated questionnaires - no interventions applied. Receives: Device: fluid biopsy capsule | |
| Crohns Disease | As confirmed by diagnosis and/or PI assessment, and measured via patient response to validated questionnaires - no interventions applied. Receives: Device: fluid biopsy capsule | |
| Ulcerative Colitis | As confirmed by diagnosis and/or PI assessment, and measured via patient response to validated questionnaires - no interventions applied. Receives: Device: fluid biopsy capsule | |
| Celiac Disease | As confirmed by diagnosis and/or PI assessment, and measured via patient response to validated questionnaires - no interventions applied. Receives: Device: fluid biopsy capsule | |
| Functional Dyspepsia | As confirmed by diagnosis and/or PI assessment, and measured via patient response to validated questionnaires - no interventions applied. Receives: Device: fluid biopsy capsule | |
| Type 2 Diabetes | As confirmed by diagnosis and/or PI assessment, and measured via patient response to validated questionnaires - no interventions applied. Receives: Device: fluid biopsy capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, pre-procedure
Secondary outcomes (1)
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.
Measured: baseline, pre-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start9 Jan 2023
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nimble Science Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mitacs, University of Calgary
- Responsible party
- Sponsor
- Investigators
- Chris Andrews, MD, Principal investigator, Nimble Science Ltd.Matthew Woo, MD, Principal investigator, Nimble Science Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633706
- Sponsor's protocol ID
- HREBA.CTC-22-0096
- Status last verified
- Sep 2026
- First submitted
- 26 Sep 2022
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No