Evaluation of the SIMBA Capsule for Small Intestinal Dysbiosis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Aged between 18 and 80 years. 2. No previous diagnosis of Celiac Disease, Ulcerative Colitis, Crohn's disease, IBS, Functional Dyspepsia by participant self-report (Control group). 3. Prior diagnosis of Celiac Disease, Ulcerative Colitis, Crohn's disease, IBS, or Functional Dyspepsia 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, prokinetics, anticholinergics, laxatives), or acidity (PPI, H2RA) (Control Group only). 3. History of oropharyngeal dysphagia or other swallowing disorder with a risk of aspiration of the capsule. 4. 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). 5. No antibiotics, or colon cleanses/bowel prep for 2 weeks. 6. < 2 bowel movements per week (Control Group only).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Nimble Science Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Chris Andrews, MDMatthew Woo, MD
Principal Investigator Affiliation Nimble Science Ltd.Nimble Science Ltd.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries Canada

The disease, disorder, syndrome, illness, or injury that is being studied.

Irritable Bowel Syndrome, Crohn Disease, Celiac Disease, Ulcerative Colitis, Functional Dyspepsia
Additional Details

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.

Arms & Interventions


: 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.


Device: - fluid biopsy capsule

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Nimble Science, Calgary, Alberta, Canada




Nimble Science

Calgary, Alberta, T2P 3P2

Site Contact

Sabina Bruehlmann, PhD



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