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Dietary Intervention Detection in the Small Intestine

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ClinicalTrials.gov Identifier: NCT04489329
Recruitment Status : Active, not recruiting
First Posted : July 28, 2020
Last Update Posted : February 18, 2021
Sponsor:
Collaborators:
University of Calgary
Lallemand Health Solutions
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Proof of Concept Device: Ingestible Capsule Dietary Supplement: Probiotic Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Use of the Small Intestine Microbiome Aspiration (SIMBA) Capsule to Detect a Dietary Intervention in the Small Intestine
Actual Study Start Date : December 22, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

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.




Primary Outcome Measures :
  1. Bacterial density count [ Time Frame: 7 days ]
    density count of probiotic strain compared between capsule and stool sample (CFU/ml)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04489329


Locations
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Canada, Alberta
Cumming School of Medicine
Calgary, Alberta, Canada, T2N 4Z6
Sponsors and Collaborators
Nimble Science Ltd.
University of Calgary
Lallemand Health Solutions
Investigators
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Principal Investigator: Chris Andrews, MD MSc University of Calgary
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Responsible Party: Nimble Science Ltd.
ClinicalTrials.gov Identifier: NCT04489329    
Other Study ID Numbers: REB 20-1211
First Posted: July 28, 2020    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No