Microbiome Collection Device Study

Enrolling healthy volunteers

Enrolling volunteers with IBS

Microbe Photo

Ever wonder what's living inside your gut?

We are enrolling volunteers for a clinical research study to test a new device that will sample your microbiome directly. We are looking for 10 adult participants who have not been previously diagnosed with a gastrointestinal (GI) disorder such as IBS, IBD or SIBO for this study and 20 who have active IBS, either with diarrhea or constipation. Study visits are expected to begin in November 2021.

This new device is small and is swallowed. It is designed to collect a sample in the small intestine as it passes through your GI tract. The capsules are collected from stool in the days following ingestion.

The study will take about 3 weeks to complete and will involve two visits to clinic and some data collection at home. One of the visits will take about 6 hours at the Foothills Medical Centre. Procedures include swallowing 2 study capsules and a sedated upper endoscopy to check your esophagus, stomach and small intestine and obtain a sample of intestinal contents. You will be required to collect these 2 capsules from stool in the following days. A separate visit at an X-ray clinic will take about 4 hours and will include swallowing 2 study capsules, a series of X-rays and at home collection in the days following the visit. In addition, we will provide you with a kit to complete a breath test for small intestine bacterial overgrowth (SIBO) at home. We will share the results of the endoscopy and breath test with you at the end of the study. Compensation for time and travel will be provided.

You may be eligible if you are aged between 18 and 70 years and meet the following criteria:

  1. Diagnosis of IBS by Rome 4 criteria (IBS groups) or no previous diagnosis of IBS or suspected IBS (Control group)
  2. Ability to understand and provide informed consent.
  3. Ability and willingness to meet the required schedule and study interventions.
  4. No planned change in diet or medical interventions during the study duration.
  5. Adequate mobility to transfer repeatedly between X-ray (standing or lying), and waiting (sitting).
  6. Willing and able to undergo a sedated esophagogastroduodenoscopy (EGD) with aspirate and brushings.

You are not eligible if any of the following apply:

  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)

Additional screening questions apply.

The University of Calgary Conjoint Health Research Ethics Board has approved this study REB19-0957