Validation of the Small Intestine Microbiome Aspiration (SIMBA) Capsule

NCT04094558 | Completed

• 1 other identifier: 19-0957
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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)

  same day

• 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)

  same day

Secondary Outcomes (1)

• Bacterial composition

  within 5 days of primary measures

Study Arms (3)

IBS-D

ACTIVE COMPARATOR

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

Device: Ingestible capsule; Procedure: Sedated EGD; Diagnostic Test: Lactulose Breath Test

IBS-C

ACTIVE COMPARATOR

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

Device: Ingestible capsule; Procedure: Sedated EGD; Diagnostic Test: Lactulose Breath Test

Healthy Control

ACTIVE COMPARATOR

Participant with no ongoing medical conditions affecting GI health.

Device: Ingestible capsule; Procedure: Sedated EGD; Diagnostic Test: Lactulose Breath Test

Interventions

Ingestible capsule DEVICE

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

Healthy Control; IBS-C; IBS-D

Sedated EGD PROCEDURE

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

Healthy Control; IBS-C; IBS-D

Lactulose Breath Test DIAGNOSTIC_TEST

Hydrogen and methane breath test with lactulose substrate

Healthy Control; IBS-C; IBS-D

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Calgary: lead
• Nimble Science Ltd.: collaborator

Study Sites (1)

Cumming School of Medicine, University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Christopher N Andrews

  Cumming School of Medicine, University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 19, 2019
• Study Start: October 27, 2021
• Primary Completion: June 16, 2022
• Study Completion: June 16, 2022
• Last Updated: September 2, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)