Evaluation of the SIMBA Capsule for gut health issues

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

This study is testing a new capsule that people will swallow to see how it can help us understand gut health issues by collecting samples from their small intestine.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Nimble Science Ltd. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Calgary, Alberta)
• Trial ID: NCT05633706 on ClinicalTrials.gov

What this trial studies

This study evaluates the SIMBA Capsule, a non-invasive ingestible device designed to sample small bowel contents mechanically. Participants will ingest up to four capsules on two occasions, providing samples for microbial and metabolomic analysis, while also completing questionnaires about their gastrointestinal symptoms and lifestyle factors. The goal is to correlate gut symptoms with dysbiosis in the small intestinal microbiome, potentially identifying biomarkers for various functional gut disorders. This research aims to enhance understanding of the microbiome's role in gastrointestinal health.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 80 with diagnosed gastrointestinal conditions like IBS, Crohn's disease, or functional dyspepsia.

Not a fit: Patients with known conditions that could obstruct the intestines or those with a prior diagnosis of Celiac Disease or similar disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic tools for managing functional gut disorders.

How similar studies have performed: While the approach of using ingestible capsules for microbiome analysis is gaining traction, this specific methodology is relatively novel and has not been extensively tested in similar studies.

Eligibility criteria

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).

Where this trial is running

Calgary, Alberta

• Nimble Science — Calgary, Alberta, Canada (Recruiting)

Study contacts

• Principal investigator: Chris Andrews, MD — Nimble Science Ltd.
• Study coordinator: Gwen Duytschaever, PhD

Conditions Irritable Bowel Syndrome; Crohn Disease; Celiac Disease; Ulcerative Colitis; Functional Dyspepsia; Type 2 Diabetes; Healthy; Microbiome