Evaluation of the SIMBA Capsule for Small Intestinal Dysbiosis
Recruiting · NCT05633706 · Observational (researchers observe without assigning treatment) · Lead sponsor: Nimble Science Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
fluid biopsy capsule
What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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.
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, 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).
Where it is running
3 locations listed.
- Nimble Science - Calgary, Alberta, Canada
- Nimble Science - Calgary, Alberta, Canada
- Nimble Science - Calgary, Alberta, Canada