Validation of the Small Intestine Microbiome Aspiration (SIMBA) Capsule

Prospective, open label trial to establish the ability of the SIMBA Capsule to accurately obtain a sample from the small bowel of participants with IBS (10 constipation-predominant (IBS-C) and 10 diarrhea-predominant (IBS-D)) and healthy participants (n=10). The accuracy of targeting the small bowel will be established by visual confirmation via X-ray. The clinical utility of the collected sample will be evaluated by analysis with samples obtained by the current gold standard (duodenal aspirate), as well as stool analysis and LBT.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome; Proof of Concept
• Intervention / Treatment: Device: Ingestible capsule; Procedure: Sedated EGD; Diagnostic test: Lactulose Breath Test

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • Cumming School of Medicine, University of Calgary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

1. Aged between 18 and 70 years.
2. Diagnosis of IBS by Rome 4 criteria (IBS groups) or no previous diagnosis of IBS or suspected IBS (Control group).
3. Ability to understand and provide informed consent.
4. Ability and willingness to meet the required schedule and study interventions.
5. No planned change in diet or medical interventions during the study duration.
6. Adequate mobility to transfer repeatedly between X-ray (standing or lying), and waiting (sitting).
7. Willing and able to undergo a sedated esophagogastroduodenoscopy (EGD) with aspirate and brushing.

Exclusion Criteria

1. Prior gastrointestinal disease, surgery, or radiation treatment 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, Crohn's disease, 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).
2. Use of any medications in the previous week that could substantially alter gastrointestinal motor function (e.g., opioids, prokinetics, anticholinergics, laxatives), or acidity (PPI, H2RA).
3. History of oropharyngeal dysphagia or other swallowing disorder with a risk of aspiration of the capsule.
4. Females of childbearing age who are not practicing birth control and/or are pregnant or lactating.
5. No antibiotics, or colon cleanses/bowel prep for 2 weeks.
6. < 2 bowel movements per week (Control Group).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: IBS-D; Participant diagnosed with Irritable Bowel Syndrome, diarrhea predominant, confirmed by study doctors using Rome IV criteria.	Device: Ingestible capsule; Participants will swallow capsules and collect in stool concurrent with stool samples; Procedure: Sedated EGD; Participants will undergo sedated esophagogastroduodenoscopy (EGD) for collection of small intestine aspirate and simultaneous saliva sample.; Diagnostic test: Lactulose Breath Test; Hydrogen and methane breath test with lactulose substrate
Active Comparator: IBS-C; Participant diagnosed with Irritable Bowel Syndrome, constipation predominant, confirmed by study doctors using Rome IV criteria.	Device: Ingestible capsule; Participants will swallow capsules and collect in stool concurrent with stool samples; Procedure: Sedated EGD; Participants will undergo sedated esophagogastroduodenoscopy (EGD) for collection of small intestine aspirate and simultaneous saliva sample.; Diagnostic test: Lactulose Breath Test; Hydrogen and methane breath test with lactulose substrate
Active Comparator: Healthy Control; Participant with no ongoing medical conditions affecting GI health.	Device: Ingestible capsule; Participants will swallow capsules and collect in stool concurrent with stool samples; Procedure: Sedated EGD; Participants will undergo sedated esophagogastroduodenoscopy (EGD) for collection of small intestine aspirate and simultaneous saliva sample.; Diagnostic test: Lactulose Breath Test; Hydrogen and methane breath test with lactulose substrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacterial composition	1. Correlations of bacterial composition (superimposability of PLS-DA mapping) of samples collected by the SIMBA Capsule compared to small bowel aspirate and to mucosal microbiome sample obtained by brushing. (hypothesis: findings will be similar)	same day
Bacterial composition	2. Correlations of bacterial composition (superimposability of PLS-DA mapping) of samples collected by the SIMBA Capsule compared to stool sample obtained at same time. (hypothesis: findings will be different)	same day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacterial composition	1. Correlation of hydrogen- and methane-producing bacteria species (by 16s RNA sequencing) found by SIMBA Capsule with hydrogen and methane concentrations (peak and rise in ppm) detected by LBT and bacterial density (CFU/ml) of endoscopic aspirate.	within 5 days of primary measures

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Nimble Science Ltd.
• Investigators: Principal Investigator: Christopher N Andrews, Cumming School of Medicine, University of Calgary

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2021
• Primary Completion (Actual): June 16, 2022
• Study Completion (Actual): June 16, 2022

Study Registration Dates

• First Submitted: September 17, 2019
• First Submitted That Met QC Criteria: September 18, 2019
• First Posted (Actual): September 19, 2019

Study Record Updates

• Last Update Posted (Actual): September 2, 2022
• Last Update Submitted That Met QC Criteria: August 31, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Irritable Bowel Syndrome; Gastrointestinal Agents; Lactulose
• Other Study ID Numbers: 19-0957

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No