Evaluation of the SIMBA Capsule for Small Intestinal Dysbiosis

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05633706
• Other study ID #: HREBA.CTC-22-0096
• Status: Recruiting
• Start date: January 9, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: December 2023
• Source: Nimble Science Ltd.
• Contact: Sabina Bruehlmann, PhD
• Phone: 4038625777
• Email: sabina[@]nimblesci.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 1, 2025
• Est. primary completion date: December 30, 2024
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Celiac Disease
• Crohn Disease
• Dysbiosis
• Dyspepsia
• Functional Dyspepsia
• Irritable Bowel Syndrome
• Ulcerative Colitis

Intervention

Device:
• fluid biopsy capsule
Collection of a fluid biopsy from the small intestine via ingestible capsule

Locations

Country	Name	City	State
Canada	Nimble Science	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
Nimble Science Ltd.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Usability of SIMBA capsule in various disease states as assessed by SIMBA-experience questionnaires.	Participant feedback on SIMBA capsule usage experience will inform usability data.	immediately after the procedure
Other	Comparison of SIMBA fluid biopsy microbial composition to stool microbial composition as assessed by 16s rRNA metagenomic analysis.		baseline, pre-procedure
Other	Correlations of bacterial composition with anxiety (GAD-7) scores as assessed by PCoA mapping, alpha and beta diversity analysis.		baseline, pre-procedure
Other	Correlations of bacterial composition with depression (PHQ-8) scores as assessed by PCoA mapping, alpha and beta diversity analysis.		baseline, pre-procedure
Other	Correlations of bacterial composition with self-reported lifestyle behaviours as assessed by PCoA mapping, alpha and beta diversity analysis.		baseline, pre-procedure
Other	Number of participants with device-related adverse events as assessed by an independent Data Safety Monitoring Board.		through study completion, an average of 8 days
Other	Evaluate the usability of excreted SIMBA Capsule retrieval procedures as assessed by retrieval-experience questionnaire feedback.		immediately after the procedure
Primary	Correlation of bacterial composition with gastrointestinal disease states as assessed by PLS-DA mapping.	The bacterial composition of healthy control fluid biopsy is compared to the bacterial composition of participants with diagnosed gastrointestinal diseases, to aid in gastrointestinal disease biomarker discovery.	baseline, pre-procedure
Secondary	Correlation of bacterial composition with dietary intake as assessed by PLS-DA mapping.	Fluid biopsy bacterial composition correlated with self-reported long-term and short-term preferred variations in intake of dietary fiber and organic food.	baseline, pre-procedure