NCT04094558

Validation of the Small Intestine Microbiome Aspiration (SIMBA) Capsule

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2021-10-27
• Primary completion: 2022-06-16
• Completion: 2022-06-16
• First posted: 2019-09-19
• Last updated: 2022-09-02

Locations

1 site across 1 country: Canada