Validation of the Small Intestine Microbiome Aspiration (SIMBA) Capsule

Irritable Bowel Syndrome Clinical Trial

Official title:

Validation of the Small Intestine Microbiome Aspiration (SIMBA) Capsule

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04094558
• Other study ID #: 19-0957
• Status: Completed
• Phase: N/A
• Start date: October 27, 2021
• Est. completion date: June 16, 2022

Study information

• Verified date: June 2022
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 16, 2022
• Est. primary completion date: June 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Proof of Concept

Intervention

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

Locations

Country	Name	City	State
Canada	Cumming School of Medicine, University of Calgary	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Nimble Science Ltd.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	within 5 days of primary measures