RecruitingNCT05633706

Evaluation of the SIMBA Capsule for Small Intestinal Dysbiosis

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

Sponsor

Nimble Science Ltd.

Enrollment

300 participants

Start Date

Jan 9, 2023

Study Type

OBSERVATIONAL

Conditions

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

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

\. 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 Criteria11

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).