Evaluation of the SIMBA Capsule for Small Intestinal Dysbiosis

NCT05633706 | Recruiting DMC

• 1 other identifier: HREBA.CTC-22-0096
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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; Type 2 Diabetes; Healthy

Keywords

Microbiome

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline, pre-procedure

Secondary Outcomes (1)

• Correlation of bacterial composition with dietary intake as assessed by PLS-DA mapping.

  baseline, pre-procedure

Other Outcomes (7)

• Usability of SIMBA capsule in various disease states as assessed by SIMBA-experience questionnaires.

  immediately after the procedure

• Comparison of SIMBA fluid biopsy microbial composition to stool microbial composition as assessed by 16s rRNA metagenomic analysis.

  baseline, pre-procedure

• Correlations of bacterial composition with anxiety (GAD-7) scores as assessed by PCoA mapping, alpha and beta diversity analysis.

  baseline, pre-procedure

Study Arms (7)

Healthy

Not belonging to the other cohorts as described below.

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.

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.

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.

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.

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.

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.

Device: fluid biopsy capsule

Interventions

fluid biopsy capsule DEVICE

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

Celiac Disease; Crohns Disease; Functional Dyspepsia; Healthy; Irritable Bowel Syndrome; Type 2 Diabetes; Ulcerative Colitis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Up to 300 individuals, females or males will be enrolled in this study.

You may qualify if:

• \. 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Nimble Science Ltd.: lead
• Mitacs: collaborator
• University of Calgary: collaborator

Study Sites (1)

Nimble Science

Calgary, Alberta, T2P 3P2, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Fluid from the small intestine, stool, saliva

MeSH Terms

Conditions

Irritable Bowel Syndrome; Crohn Disease; Celiac Disease; Colitis, Ulcerative; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Gastroenteritis; Malabsorption Syndromes; Metabolic Diseases; Nutritional and Metabolic Diseases; Colitis; Diabetes Mellitus; Glucose Metabolism Disorders; Endocrine System Diseases

Study Officials

• Chris Andrews, MD

  Nimble Science Ltd.

  PRINCIPAL INVESTIGATOR

• Matthew Woo, MD

  Nimble Science Ltd.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gwen Duytschaever, PhD

CONTACT

8664934633; clinical@nimblesci.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: December 1, 2022
• Study Start: January 9, 2023
• Primary Completion: June 6, 2025
• Study Completion: June 6, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)