Dietary Intervention Detection in the Small Intestine
Study Details
Study Description
Brief Summary
Proof of concept study to validate the ability of a capsule device to gather samples from the small bowel for microbiome analysis in adults and to detect dietary changes from simultaneous ingestion of a probiotic.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Single Arm Participant swallows and retrieves capsule in stool before and after ingestion of a probiotic. Capsule and stool samples are analyzed for presence of probiotic strain and compared to baseline. |
Device: Ingestible Capsule
Participants will swallow capsule and undergo X-rays to establish transit
Dietary Supplement: Probiotic
Participants will swallow a probiotic capsule and the sample collection capsule at the same time to establish concentration of strain in small intestine.
|
Outcome Measures
Primary Outcome Measures
- Bacterial density count [7 days]
density count of probiotic strain compared between capsule and stool sample (CFU/ml)
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 to 65 years old
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Healthy
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On no medication, or on stable doses of medications which will not be changed over the course of the study
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Willingness to maintain their usual dietary habits and physical activity
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Willing to discontinue consumption of fermented foods or probiotics (such as kombucha, yogurts with live, active cultures, or probiotic supplements) for the duration of the study.
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Ability to understand and provide informed consent
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Ability and willingness to meet the required schedule and study tasks and interventions
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Willing to fast for at least 8 hours before the 2 intake visits (Visit 1 and Visit 2)
Exclusion Criteria:
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History of a small intestine obstruction of symptoms of an intermittent small intestine obstruction (i.e., recurrent abdominal pain, distention, nausea and vomiting).
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Pregnant or breastfeeding or planning on becoming pregnant during study timeline.
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Use of other investigational product within 3 months of start of the study.
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Suffering from immune disorders or with possible immune deficient status
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Allergy to soy or milk.
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Prior gastrointestinal surgery which has altered the anatomy of the esophagus, stomach or small or large intestine (exceptions include appendectomy or cholecystectomy more than 3 months prior to enrollment).
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Use of any medications in the previous 7 days that could substantially alter gastrointestinal motor function (e.g. opioids, prokinetics, anticholinergics, laxatives), acidity (PPI, H2RA), or integrity (NSAIDs, oral steroids).
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Body Mass Index (BMI) > 38.
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Previous history of gastric bezoar or gastroparesis.
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Any abdominal or pelvic surgery within the past 3 months.
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Known history of inflammatory bowel disease and/or Crohn's disease.
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History of diverticulitis, diverticular stricture, or other intestinal strictures.
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History of abdominal or pelvic radiotherapy.
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History of dysphagia, eosinophilic esophagitis, esophageal stricture, or other swallowing disorder.
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Cardiovascular, endocrine, renal or other chronic disease likely to affect motility.
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Colon cleansing prep for 1 month before the first visit, or during the study.
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Use of antibiotics, prebiotics, herbal supplements, or probiotics for 2 weeks before the first visit, or during the study.
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< 2 bowel movements per week.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cumming School of Medicine | Calgary | Alberta | Canada | T2N 4Z6 |
Sponsors and Collaborators
- Nimble Science Ltd.
- University of Calgary
- Lallemand Health Solutions
Investigators
- Principal Investigator: Chris Andrews, MD MSc, University of Calgary
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- REB 20-1211