Validation of the Small Intestine Microbiome Aspiration (SIMBA) Capsule

Not Applicable

Completed

• Conditions: Proof of Concept; Irritable Bowel Syndrome
• Interventions: Device: Ingestible capsule; Procedure: Sedated EGD; Diagnostic Test: Lactulose Breath Test

• Registration Number: NCT04094558
• Lead Sponsor: University of Calgary

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-09-17
• Study First Submitted QC: 2019-09-18
• Study First Posted: 2019-09-19
• Study Start: 2021-10-27
• Status Verified: 2022-06
• Primary Completion: 2022-06-16
• Study Completion: 2022-06-16
• Last Update Submitted: 2022-08-31
• Last Update Posted: 2022-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IBS-D	Lactulose Breath Test	Participant diagnosed with Irritable Bowel Syndrome, diarrhea predominant, confirmed by study doctors using Rome IV criteria.
IBS-C	Ingestible capsule	Participant diagnosed with Irritable Bowel Syndrome, constipation predominant, confirmed by study doctors using Rome IV criteria.
Healthy Control	Sedated EGD	Participant with no ongoing medical conditions affecting GI health.
Healthy Control	Lactulose Breath Test	Participant with no ongoing medical conditions affecting GI health.
IBS-D	Sedated EGD	Participant diagnosed with Irritable Bowel Syndrome, diarrhea predominant, confirmed by study doctors using Rome IV criteria.
IBS-C	Lactulose Breath Test	Participant diagnosed with Irritable Bowel Syndrome, constipation predominant, confirmed by study doctors using Rome IV criteria.
IBS-D	Ingestible capsule	Participant diagnosed with Irritable Bowel Syndrome, diarrhea predominant, confirmed by study doctors using Rome IV criteria.
IBS-C	Sedated EGD	Participant diagnosed with Irritable Bowel Syndrome, constipation predominant, confirmed by study doctors using Rome IV criteria.
Healthy Control	Ingestible capsule	Participant with no ongoing medical conditions affecting GI health.

Primary Outcome Measures

Name	Time	Method
Bacterial composition	same day	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)

Secondary Outcome Measures

Name	Time	Method
Bacterial composition	within 5 days of primary measures	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.

Trial Locations

Locations (1)

Cumming School of Medicine, University of Calgary; 🇨🇦 Calgary, Alberta, Canada