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Validation of Ingestible Capsule to Study Small Bowel

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04094558
Recruitment Status : Not yet recruiting
First Posted : September 19, 2019
Last Update Posted : December 2, 2019
Sponsor:
Information provided by (Responsible Party):
University of Calgary

Brief Summary:
Proof of concept study to validate the ability of the ingestible capsule to gather samples from the small bowel for microbiome analysis in adults.

Condition or disease Intervention/treatment Phase
Proof of Concept Device: Ingestible capsule Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validation of Ingestible Capsule to Study Small Bowel
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : April 2021

Arm Intervention/treatment
Experimental: Single Arm
Participant swallows and retrieves capsule in stool. Capsule and stool samples are analyzed for bacterial density and composition.
Device: Ingestible capsule
Participants will swallow capsule and undergo X-rays to establish transit.




Primary Outcome Measures :
  1. Bacterial density count [ Time Frame: same 1 day ]
    density count and comparison 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 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Aged between 18 and 70 years
  2. Diagnosis of IBS by Rome 4 criteria (Group 1) or no previous diagnosis of IBS or suspected IBS (Group 2)
  3. Ability to understand and provide informed consent
  4. Ability and willingness to meet the required schedule and study interventions
  5. Adequate mobility to transfer repeatedly between X-ray (standing), US (lying), and waiting (sitting)

Exclusion Criteria:

  1. 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).
  2. Use of any medications in the previous week that could substantially alter gastrointestinal motor function (e.g. opioids, prokinetics, anticholinergics, laxatives), or acidity (PPI, H2RA)
  3. Body Mass Index (BMI) > 38.
  4. Previous history of gastric bezoar or gastroparesis.
  5. Any abdominal or pelvic surgery within the past 3 months.
  6. Known history of inflammatory bowel disease.
  7. History of diverticulitis, diverticular stricture, or other intestinal strictures.
  8. History of abdominal or pelvic radiotherapy
  9. History of dysphagia, eosinophilic esophagitis, esophageal stricture, or other swallowing disorder
  10. Females of childbearing age who are not practicing birth control and/or are pregnant or lactating
  11. Cardiovascular, endocrine, renal or other chronic disease likely to affect motility.
  12. No colon cleansing prep for 1 month
  13. No antibiotics or probiotics for 2 weeks
  14. < 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): NCT04094558


Contacts
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Contact: Lynn Wilsack, MSc 403 592-5045 lwilsack@ucalgary.ca

Sponsors and Collaborators
University of Calgary

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Responsible Party: University of Calgary
ClinicalTrials.gov Identifier: NCT04094558    
Other Study ID Numbers: 19-0957
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: September 2019
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