Evaluation of the SIMBA Capsule for Small Intestinal Dysbiosis

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Description

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.

Study Overview

Start Date
January 9, 2023
Completion Date
January 1, 2025
Enrollment
150
Date Posted
December 1, 2022
Gender
All

Locations

Full Address
Nimble Science
Calgary, Alberta T2P 3P2, Canada

Eligibility

Study Population
Up to 150 individuals, females or males will be enrolled in this study.
Minimum Age (years)
18
Maximum Age (years)
80
Eligibility Criteria
Inclusion Criteria:

Aged between 18 and 80 years.
No previous diagnosis of Celiac Disease, Ulcerative Colitis, Crohn's disease, IBS, Functional Dyspepsia by participant self-report (Control group).
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).
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.

Exclusion Criteria:

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, prokinetics, anticholinergics, laxatives), or acidity (PPI, H2RA) (Control Group only).
History of oropharyngeal dysphagia or other swallowing disorder with a risk of aspiration of the capsule.
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).

Study Contact Info

Study Contact Name
Sabina Bruehlmann, PhD; Joseph Wang, PhD
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
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.
NCTid (if applicable)
NCT05633706