Evaluation of the Small Intestine Microbiome Aspiration (SIMBA) Capsule for Small Intestinal Dysbiosis

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Canada
Nimble Science
RECRUITING
Calgary
Contact Information
Primary
Gwen Duytschaever, PhD
clinical@nimblesci.com
8664934633
Time Frame
Start Date: 2023-01-09
Estimated Completion Date: 2025-06-06
Participants
Target number of participants: 300
Treatments
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.
Sponsors
Collaborators: Mitacs, University of Calgary
Leads: Nimble Science Ltd.

This content was sourced from clinicaltrials.gov