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Validation of the Small Intestine Microbiome Aspiration (SIMBA) Capsule

NCT04094558 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-09-02

No results posted yet for this study

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.

Conditions

  • Proof of Concept
  • Irritable Bowel Syndrome

Interventions

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

Sponsors & Collaborators

  • Nimble Science Ltd.

    collaborator INDUSTRY

  • University of Calgary

    lead OTHER

Principal Investigators

  • Christopher N Andrews · Cumming School of Medicine, University of Calgary

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-27
Primary Completion
2022-06-16
Completion
2022-06-16

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04094558 on ClinicalTrials.gov