Evaluation of the SIMBA Capsule for Small Intestinal Dysbiosis

Participation Requirements

• Sex:

  ALL

• Eligible Ages:

  18 to 80

Participation Criteria

Inclusion Criteria:

1. Aged between 18 and 80 years.
2. No previous diagnosis of Celiac Disease, Ulcerative Colitis, Crohn's disease, IBS, Functional Dyspepsia by participant self-report (Control group).
3. 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).
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, prokinetics, anticholinergics, laxatives), or acidity (PPI, H2RA) (Control Group only).
3. History of oropharyngeal dysphagia or other swallowing disorder with a risk of aspiration of the capsule.
4. 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).
5. No antibiotics, or colon cleanses/bowel prep for 2 weeks.
6. \< 2 bowel movements per week (Control Group only).