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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

Tracking Information
First Submitted Date  ICMJE September 17, 2019
First Posted Date  ICMJE September 19, 2019
Last Update Posted Date December 2, 2019
Estimated Study Start Date  ICMJE February 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2019)
Bacterial density count [ Time Frame: same 1 day ]
density count and comparison between capsule and stool sample (CFU/ml)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Validation of Ingestible Capsule to Study Small Bowel
Official Title  ICMJE Validation of Ingestible Capsule to Study Small Bowel
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Proof of Concept
Intervention  ICMJE Device: Ingestible capsule
Participants will swallow capsule and undergo X-rays to establish transit.
Study Arms  ICMJE Experimental: Single Arm
Participant swallows and retrieves capsule in stool. Capsule and stool samples are analyzed for bacterial density and composition.
Intervention: Device: Ingestible capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 18, 2019)
22
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Lynn Wilsack, MSc 403 592-5045 lwilsack@ucalgary.ca
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04094558
Other Study ID Numbers  ICMJE 19-0957
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Calgary
Study Sponsor  ICMJE University of Calgary
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Calgary
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP