Validation of the Small Intestine Microbiome Aspiration (SIMBA) Capsule

NCT ID: NCT04094558

Last Updated: 2022-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-27
• Study Completion Date: 2022-06-16

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.

Conditions

Proof of Concept; Irritable Bowel Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

IBS-D

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

Group Type: ACTIVE_COMPARATOR

Ingestible capsule

Intervention Type: DEVICE

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

Sedated EGD

Intervention Type: PROCEDURE

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

Lactulose Breath Test

Intervention Type: DIAGNOSTIC_TEST

Hydrogen and methane breath test with lactulose substrate

IBS-C

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

Group Type: ACTIVE_COMPARATOR

Ingestible capsule

Intervention Type: DEVICE

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

Sedated EGD

Intervention Type: PROCEDURE

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

Lactulose Breath Test

Intervention Type: DIAGNOSTIC_TEST

Hydrogen and methane breath test with lactulose substrate

Healthy Control

Participant with no ongoing medical conditions affecting GI health.

Group Type: ACTIVE_COMPARATOR

Ingestible capsule

Intervention Type: DEVICE

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

Sedated EGD

Intervention Type: PROCEDURE

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

Lactulose Breath Test

Intervention Type: DIAGNOSTIC_TEST

Hydrogen and methane breath test with lactulose substrate

Interventions

Ingestible capsule

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

Intervention Type: DEVICE

Sedated EGD

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

Intervention Type: PROCEDURE

Lactulose Breath Test

Hydrogen and methane breath test with lactulose substrate

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nimble Science Ltd.

INDUSTRY

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher N Andrews

Role: PRINCIPAL_INVESTIGATOR

Cumming School of Medicine, University of Calgary

Locations

Cumming School of Medicine, University of Calgary

Calgary, Alberta, Canada

Countries

Canada

Other Identifiers

19-0957

Identifier Type: -

Identifier Source: org_study_id