Dietary Intervention Detection in the Small Intestine
Not Applicable
Completed
- Conditions
- Proof of Concept
- Registration Number
- NCT04489329
- Lead Sponsor
- Nimble Science Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Bacterial density count 7 days density count of probiotic strain compared between capsule and stool sample (CFU/ml)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cumming School of Medicine
🇨🇦Calgary, Alberta, Canada
Cumming School of Medicine🇨🇦Calgary, Alberta, Canada