Dietary Intervention Detection in the Small Intestine

Use of the Small Intestine Microbiome Aspiration (SIMBA) Capsule to Detect a Dietary Intervention in the Small Intestine

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.

Study Overview

• Status: Completed
• Conditions: Proof of Concept
• Intervention / Treatment: Device: Ingestible Capsule; Dietary supplement: Probiotic

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • Cumming School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacterial density count	density count of probiotic strain compared between capsule and stool sample (CFU/ml)	7 days

Collaborators and Investigators

• Sponsor: Nimble Science Ltd.
• Collaborators: University of Calgary; Lallemand Health Solutions
• Investigators: Principal Investigator: Chris Andrews, MD MSc, University of Calgary

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 22, 2020
• Primary Completion (ACTUAL): February 24, 2021
• Study Completion (ACTUAL): February 24, 2021

Study Registration Dates

• First Submitted: July 23, 2020
• First Submitted That Met QC Criteria: July 23, 2020
• First Posted (ACTUAL): July 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 8, 2021
• Last Update Submitted That Met QC Criteria: September 6, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: REB 20-1211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No