Clinical trial NCT05633706: Evaluation of the SIMBA Capsule for Small Intestinal Dysbiosis
Official title: Evaluation of the Small Intestine Microbiome Aspiration (SIMBA) Capsule for Small Intestinal Dysbiosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Irritable Bowel Syndrome
Crohn Disease
Celiac Disease
Ulcerative Colitis
Functional Dyspepsia
Type 2 Diabetes
Healthy
Keywords: Microbiome
Lead sponsor: Nimble Science Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Mitacs
name: University of Calgary
First posted: 2022-12-01
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Up to 300 individuals, females or males will be enrolled in this study.

Brief 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.

Detailed description: The investigators primary goal is to assess the correlation of gut symptoms from various disease states with the dysbiosis of the small intestinal microbiome and metabolites collected by the SIMBA capsule, and as identified and measured by metagenomic sequencing and/or metabolomics approaches. The process consists of ingestion and collection of up to 4 SIMBA capsules, on up to 2 separate occasions, along with collection of a stool sample at the same time. Participants will also fill out a series of questionnaires on medical history and lifestyle inputs (eg. diet, exercise, mental health) GI symptoms, anxiety, and depression. The investigators ultimate goal will be to develop a better understanding of how the small intestinal microbiome might play a role in symptom generation, to establish whether the SIMBA capsule can find a signature of dysbiosis which can be used as a biomarker for a number of functional gut disorders.

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).

Primary outcomes:
measure: Correlation of bacterial composition with gastrointestinal disease states as assessed by PLS-DA mapping.
timeFrame: baseline, pre-procedure
Secondary outcomes:
measure: Correlation of bacterial composition with dietary intake as assessed by PLS-DA mapping.
timeFrame: baseline, pre-procedure
Other outcomes:
measure: Usability of SIMBA capsule in various disease states as assessed by SIMBA-experience questionnaires.
timeFrame: immediately after the procedure
measure: Comparison of SIMBA fluid biopsy microbial composition to stool microbial composition as assessed by 16s rRNA metagenomic analysis.
timeFrame: baseline, pre-procedure
measure: Correlations of bacterial composition with anxiety (GAD-7) scores as assessed by PCoA mapping, alpha and beta diversity analysis.
timeFrame: baseline, pre-procedure
measure: Correlations of bacterial composition with depression (PHQ-8) scores as assessed by PCoA mapping, alpha and beta diversity analysis.
timeFrame: baseline, pre-procedure
measure: Correlations of bacterial composition with self-reported lifestyle behaviours as assessed by PCoA mapping, alpha and beta diversity analysis.
timeFrame: baseline, pre-procedure
measure: Number of participants with device-related adverse events as assessed by an independent Data Safety Monitoring Board.
timeFrame: through study completion, an average of 8 days
measure: Evaluate the usability of excreted SIMBA Capsule retrieval procedures as assessed by retrieval-experience questionnaire feedback.
timeFrame: immediately after the procedure
Locations:
city: Calgary
country: Canada
facility: Nimble Science
state: Alberta
Study officials:
affiliation: Nimble Science Ltd.
name: Chris Andrews, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nimble Science Ltd.
name: Matthew Woo, MD
role: PRINCIPAL_INVESTIGATOR
References: