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Proof of ConceptNCT04094558

Validation of the Small Intestine Microbiome Aspiration (SIMBA) Capsule

A study testing Ingestible capsule, Sedated EGD and Lactulose Breath Test in people with Proof of Concept and Irritable Bowel Syndrome, run by University of Calgary at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Proof of Concept, Irritable Bowel Syndrome
What is being tested?
Ingestible capsule, Sedated EGD and Lactulose Breath Test
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteCanada
Study dates
27 Oct 2021to 16 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Cumming School of Medicine, University of Calgary

    Calgary, Alberta, T2N 4Z6

Other trials in Canada

About this study

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.

Being tested
Ingestible capsule, Sedated EGD, Lactulose Breath Test
Medical subject headings
Irritable Bowel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ingestible capsuleDevice

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

  • Sedated EGDProcedure or surgery

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

  • Lactulose Breath TestDiagnostic test

    Hydrogen and methane breath test with lactulose substrate

Study groups in NCT04094558
Study groupRoleWhat they receive
IBS-DActive comparatorParticipant diagnosed with Irritable Bowel Syndrome, diarrhea predominant, confirmed by study doctors using Rome IV criteria.
Receives: Device: Ingestible capsule; Procedure: Sedated EGD; Diagnostic Test: Lactulose Breath Test
IBS-CActive comparatorParticipant diagnosed with Irritable Bowel Syndrome, constipation predominant, confirmed by study doctors using Rome IV criteria.
Receives: Device: Ingestible capsule; Procedure: Sedated EGD; Diagnostic Test: Lactulose Breath Test
Healthy ControlActive comparatorParticipant with no ongoing medical conditions affecting GI health.
Receives: Device: Ingestible capsule; Procedure: Sedated EGD; Diagnostic Test: Lactulose Breath Test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: same day

  2. Bacterial composition

    1. 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)

    Measured: same day

Secondary outcomes (1)

  1. 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.

    Measured: within 5 days of primary measures

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2019
  2. Study start27 Oct 2021
  3. Primary completion16 Jun 2022
  4. Study completion16 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04094558
Sponsor's protocol ID
19-0957
Status last verified
Jun 2022
First submitted
17 Sep 2019
Last updated
2 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Ingestible capsule, Sedated EGD and Lactulose Breath Test in people with Proof of Concept and Irritable Bowel Syndrome, run by University of Calgary at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bacterial composition (time frame: same day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04094558.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2022.

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