Status:
COMPLETED
Dietary Intervention Detection in the Small Intestine
Lead Sponsor:
Nimble Science Ltd.
Collaborating Sponsors:
University of Calgary
Lallemand Health Solutions
Conditions:
Proof of Concept
Eligibility:
All Genders
18-65 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 18 to 65 years old
- Healthy
- On no medication, or on stable doses of medications which will not be changed over the course of the study
- Willingness to maintain their usual dietary habits and physical activity
- 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.
- Ability to understand and provide informed consent
- Ability and willingness to meet the required schedule and study tasks and interventions
- Willing to fast for at least 8 hours before the 2 intake visits (Visit 1 and Visit 2)
Exclusion
- History of a small intestine obstruction of symptoms of an intermittent small intestine obstruction (i.e., recurrent abdominal pain, distention, nausea and vomiting).
- Pregnant or breastfeeding or planning on becoming pregnant during study timeline.
- Use of other investigational product within 3 months of start of the study.
- Suffering from immune disorders or with possible immune deficient status
- Allergy to soy or milk.
- 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).
- 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).
- Body Mass Index (BMI) \> 38.
- Previous history of gastric bezoar or gastroparesis.
- Any abdominal or pelvic surgery within the past 3 months.
- Known history of inflammatory bowel disease and/or Crohn's disease.
- History of diverticulitis, diverticular stricture, or other intestinal strictures.
- History of abdominal or pelvic radiotherapy.
- History of dysphagia, eosinophilic esophagitis, esophageal stricture, or other swallowing disorder.
- Cardiovascular, endocrine, renal or other chronic disease likely to affect motility.
- Colon cleansing prep for 1 month before the first visit, or during the study.
- Use of antibiotics, prebiotics, herbal supplements, or probiotics for 2 weeks before the first visit, or during the study.
- \< 2 bowel movements per week.
Key Trial Info
Start Date :
December 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 24 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04489329
Start Date
December 22 2020
End Date
February 24 2021
Last Update
September 8 2021
Active Locations (1)
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1
Cumming School of Medicine
Calgary, Alberta, Canada, T2N 4Z6