Clinical trial NCT04489329: Dietary Intervention Detection in the Small Intestine
Official title: Use of the Small Intestine Microbiome Aspiration (SIMBA) Capsule to Detect a Dietary Intervention in the Small Intestine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Proof of Concept
Lead sponsor: Nimble Science Ltd.
Sponsor class: INDUSTRY
Collaborators: name: University of Calgary
name: Lallemand Health Solutions
First posted: 2020-07-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

1. 18 to 65 years old
2. Healthy
3. On no medication, or on stable doses of medications which will not be changed over the course of the study
4. Willingness to maintain their usual dietary habits and physical activity
5. 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.
6. Ability to understand and provide informed consent
7. Ability and willingness to meet the required schedule and study tasks and interventions
8. Willing to fast for at least 8 hours before the 2 intake visits (Visit 1 and Visit 2)

Exclusion Criteria:

1. History of a small intestine obstruction of symptoms of an intermittent small intestine obstruction (i.e., recurrent abdominal pain, distention, nausea and vomiting).
2. Pregnant or breastfeeding or planning on becoming pregnant during study timeline.
3. Use of other investigational product within 3 months of start of the study.
4. Suffering from immune disorders or with possible immune deficient status
5. Allergy to soy or milk.
6. 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).
7. 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).
8. Body Mass Index (BMI) \> 38.
9. Previous history of gastric bezoar or gastroparesis.
10. Any abdominal or pelvic surgery within the past 3 months.
11. Known history of inflammatory bowel disease and/or Crohn's disease.
12. History of diverticulitis, diverticular stricture, or other intestinal strictures.
13. History of abdominal or pelvic radiotherapy.
14. History of dysphagia, eosinophilic esophagitis, esophageal stricture, or other swallowing disorder.
15. Cardiovascular, endocrine, renal or other chronic disease likely to affect motility.
16. Colon cleansing prep for 1 month before the first visit, or during the study.
17. Use of antibiotics, prebiotics, herbal supplements, or probiotics for 2 weeks before the first visit, or during the study.
18. \< 2 bowel movements per week.

Primary outcomes:
measure: Bacterial density count
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Cumming School of Medicine
state: Alberta
Study officials:
affiliation: University of Calgary
name: Chris Andrews, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: