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Validation of the Small Intestine Microbiome Aspiration (SIMBA) Capsule

Primary Purpose

Proof of Concept, Irritable Bowel Syndrome

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Ingestible capsule

Sedated EGD

Lactulose Breath Test

About this trial

This is an interventional diagnostic trial for Proof of Concept

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria

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

Exclusion Criteria

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).
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).
History of oropharyngeal dysphagia or other swallowing disorder with a risk of aspiration of the capsule.
Females of childbearing age who are not practicing birth control and/or are pregnant or lactating.
No antibiotics, or colon cleanses/bowel prep for 2 weeks.
< 2 bowel movements per week (Control Group).

Sites / Locations

Cumming School of Medicine, University of Calgary

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

IBS-D

IBS-C

Healthy Control

Arm Description

Participant diagnosed with Irritable Bowel Syndrome, diarrhea predominant, confirmed by study doctors using Rome IV criteria.

Participant diagnosed with Irritable Bowel Syndrome, constipation predominant, confirmed by study doctors using Rome IV criteria.

Participant with no ongoing medical conditions affecting GI health.

Outcomes

Primary Outcome Measures

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)

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)

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04094558

First Posted

September 17, 2019

Last Updated

August 31, 2022

Sponsor

University of Calgary

Collaborators

Nimble Science Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04094558

Brief Title

Validation of the Small Intestine Microbiome Aspiration (SIMBA) Capsule

Official Title

Validation of the Small Intestine Microbiome Aspiration (SIMBA) Capsule

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

October 27, 2021 (Actual)

Primary Completion Date

June 16, 2022 (Actual)

Study Completion Date

June 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Calgary

Collaborators

Nimble Science Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Proof of Concept, Irritable Bowel Syndrome

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IBS-D

Arm Type

Active Comparator

Arm Description

Participant diagnosed with Irritable Bowel Syndrome, diarrhea predominant, confirmed by study doctors using Rome IV criteria.

Arm Title

IBS-C

Arm Type

Active Comparator

Arm Description

Participant diagnosed with Irritable Bowel Syndrome, constipation predominant, confirmed by study doctors using Rome IV criteria.

Arm Title

Healthy Control

Arm Type

Active Comparator

Arm Description

Participant with no ongoing medical conditions affecting GI health.

Intervention Type

Device

Intervention Name(s)

Ingestible capsule

Intervention Description

Participants will swallow capsules and collect in stool concurrent with stool samples

Intervention Type

Procedure

Intervention Name(s)

Sedated EGD

Intervention Description

Participants will undergo sedated esophagogastroduodenoscopy (EGD) for collection of small intestine aspirate and simultaneous saliva sample.

Intervention Type

Diagnostic Test

Intervention Name(s)

Lactulose Breath Test

Intervention Description

Hydrogen and methane breath test with lactulose substrate

Primary Outcome Measure Information:

Title

Bacterial composition

Description

Time Frame

same day

Title

Bacterial composition

Description

Time Frame

same day

Secondary Outcome Measure Information:

Title

Bacterial composition

Description

Time Frame

within 5 days of primary measures

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Aged between 18 and 70 years. Diagnosis of IBS by Rome 4 criteria (IBS groups) or no previous diagnosis of IBS or suspected IBS (Control group). Ability to understand and provide informed consent. Ability and willingness to meet the required schedule and study interventions. No planned change in diet or medical interventions during the study duration. Adequate mobility to transfer repeatedly between X-ray (standing or lying), and waiting (sitting). Willing and able to undergo a sedated esophagogastroduodenoscopy (EGD) with aspirate and brushing. Exclusion Criteria 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). 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). History of oropharyngeal dysphagia or other swallowing disorder with a risk of aspiration of the capsule. Females of childbearing age who are not practicing birth control and/or are pregnant or lactating. No antibiotics, or colon cleanses/bowel prep for 2 weeks. < 2 bowel movements per week (Control Group).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christopher N Andrews

Organizational Affiliation

Cumming School of Medicine, University of Calgary

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cumming School of Medicine, University of Calgary

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4Z6

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

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Validation of the Small Intestine Microbiome Aspiration (SIMBA) Capsule

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