Evaluation of the SIMBA Capsule for Small Intestinal Dysbiosis

Phase

N/A

Condition

Celiac Disease

Ulcerative Colitis

Gastrointestinal Diseases And Disorders

Treatment

fluid biopsy capsule

Clinical Study ID

NCT05633706

HREBA.CTC-22-0096

Ages 18-80
All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

Aged between 18 and 80 years.
No previous diagnosis of Celiac Disease, Ulcerative Colitis, Crohn's disease, IBS,Functional Dyspepsia by participant self-report (Control group).
Prior diagnosis of Celiac Disease, Ulcerative Colitis, Crohn's disease, IBS, orFunctional Dyspepsia by a relevant physician, nutritionist, naturopath, etc, andwillingness to provide documentation to confirm this diagnosis or have aconsultation with the PI. (Disease group).
Ability to understand and provide informed consent.
Ability and willingness to meet the required schedule, study interventions, andquestionnaire requirements.
No planned change in diet or medical interventions during the study duration.

Exclusion

Exclusion Criteria:

Known disease which, in the investigator's opinion, would lead to intestinalstructuring or obstruction with a risk of capsule non-excretion (particular diseaseswhich would be assessed on a case-by-case basis would include, achalasia,eosinophilic esophagitis, cancer diagnosis or treatment within the past year, orprevious esophageal, gastric, small intestinal, or colonic surgery. Appendectomy orcholecystectomy more than 3 months prior to enrollment are acceptable). The maindeciding factor would be a history of obstructive symptoms in the previous 3 monthsprior to entry.
Use of any medications or having undergone procedures in the previous week thatcould substantially alter gastrointestinal motor function (e.g., opioids,prokinetics, anticholinergics, laxatives), or acidity (PPI, H2RA) (Control Grouponly).
History of oropharyngeal dysphagia or other swallowing disorder with a risk ofaspiration of the capsule.
Females of childbearing age who are pregnant or lactating by self-report. (should anX-ray be required for confirmation of capsule passage, a urine pregnancy test willbe administered beforehand).
No antibiotics, or colon cleanses/bowel prep for 2 weeks.
< 2 bowel movements per week (Control Group only).

Study Design

fluid biopsy capsule

January 09, 2023

January 01, 2025

Study 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.

Connect with a study center

Nimble Science
Calgary, Alberta T2P 3P2
Canada
Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.