Recruiting

SIMBA Capsule

Sponsor:

Nimble Science Ltd.

Code:

NCT05633706

Conditions

Irritable Bowel Syndrome

Crohn Disease

Celiac Disease

Ulcerative Colitis

Functional Dyspepsia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

fluid biopsy capsule

Study Details

Brief 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.

Conditions

Irritable Bowel Syndrome

Crohn Disease

Celiac Disease

Ulcerative Colitis

Functional Dyspepsia

Study ID

NCT05633706

Start date

Jan 9, 2023

Status verified date

Apr, 2025

Completion date

Jun 6, 2025

Anticipated

Primary completion date

Jun 6, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. 1. Aged between 18 and 80 years.
2. No previous diagnosis of Celiac Disease, Ulcerative Colitis, Crohn's disease, IBS, Functional Dyspepsia, and T2D by participant self-report (Control group).
3. 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).
4. Ability to understand and provide informed consent.
5. Ability and willingness to meet the required schedule, study interventions, and questionnaire requirements.
6. No planned change in diet or medical interventions during the study duration.

Exclusion Criteria

1. 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.
2. 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).

1. 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.
2. 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.
3. 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.
3. History of oropharyngeal dysphagia or other swallowing disorder with a risk of aspiration of the capsule.
4. History of known structural gastrointestinal abnormalities such as strictures or fistulas leading to mechanical obstruction
5. History of abdominal radiation treatment
6. 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).
7. No antibiotics, or colon cleanses/bowel prep for 2 weeks.
8. < 2 bowel movements per week (Control Group only).

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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.

Interventions

fluid biopsy capsule

Collection of a fluid biopsy from the small intestine via ingestible capsule

Primary outcome measure

  • Correlation of bacterial composition with gastrointestinal disease states as assessed by PLS-DA mapping. [ Time Frame: baseline, pre-procedure ]

Central Contacts and Locations

Central contacts

Gwen Duytschaever, PhD

8664934633clinical@nimblesci.com

Locations

Nimble Science

Recruiting

Calgary, Alberta, Canada, T2P 3P2

Contacts

Gwen Duytschaever, PhD

8664934633clinical@nimblesci.com

Principal Investigator:

Chris Andrews, MD

More Information

Sponsor

Nimble Science Ltd.

Last update posted

Apr 15, 2025

Last verified

Apr, 2025

Keywords

  • Microbiome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-20. This information was provided to ClinicalTrials.gov by Nimble Science Ltd. on 2025-04-15.