Evaluation of the SIMBA Capsule for Small Intestinal Dysbiosis

Launched by NIMBLE SCIENCE LTD. · Nov 21, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the SIMBA Capsule, which is a small, single-use capsule that you swallow. The purpose of the trial is to see how well this capsule can collect samples from your small intestine without needing any invasive procedures. Researchers will examine these samples to learn about the microorganisms present and how they might relate to symptoms in people with conditions like Irritable Bowel Syndrome (IBS), Crohn's disease, Celiac disease, Ulcerative Colitis, and Functional Dyspepsia. Participants will also fill out questionnaires about their symptoms and provide stool samples for comparison.

To be eligible for the trial, you need to be between 18 and 80 years old and be willing to participate. If you have been diagnosed with one of the mentioned conditions, you can join the disease group, while those without these diagnoses can participate in the control group. Throughout the study, participants will need to follow a schedule and complete some questionnaires, but they should not make any major changes to their diet or medications during this time. It's important to know that certain health conditions or recent medications may prevent someone from participating, so it's best to discuss any concerns with a healthcare provider.

Gender

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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).