Back to resultsImpact of Diet on Capsule Endoscopy
Primary Purpose
Small Bowel Disease
Status
Unknown status
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Capsule endoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Small Bowel Disease
Eligibility Criteria
Inclusion Criteria:
- Adult patients undergoing capsule endoscopy study
Exclusion Criteria:
- Not being able to follow a diet with increased amount of fat
Sites / Locations
- Hospital BritanicoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Increased Fat Diet
Low Fat Diet
Arm Description
Outcomes
Primary Outcome Measures
Small bowel transit time
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03321669
Brief Title
Impact of Diet on Capsule Endoscopy
Official Title
Impact of Diet on Capsule Endoscopy Transit Time - a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 4, 2017 (Actual)
Primary Completion Date
December 1, 2018 (Anticipated)
Study Completion Date
December 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Britanico
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Capsule endoscopy studies are used for the diagnosis of small bowel mucosal lesions. Since capsule endoscopy depends on the small intestinal peristaltism, the food intake - especially the amount of fat ingested - after the ingestion of the capsule may have an impact on the capsule endoscopy transit time and thus its diagnostic yield. As a consequence, an open-label randomized pilot study was designed to determine wether increased dietary intake of fat after the ingestion of the capsule endoscopy may influence small intestinal transit time and thus the diagnosis of small bowel lesions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Bowel Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Increased Fat Diet
Arm Type
Active Comparator
Arm Title
Low Fat Diet
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
Capsule endoscopy
Intervention Description
Ingestion of capsule endoscopy for the diagnosis of small bowel lesions
Primary Outcome Measure Information:
Title
Small bowel transit time
Time Frame
12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients undergoing capsule endoscopy study
Exclusion Criteria:
Not being able to follow a diet with increased amount of fat
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan S Lasa, MD
Phone
(54911)40848182
Email
drjuanslasa@gmail.com
Facility Information:
Facility Name
Hospital Britanico
City
Buenos Aires
ZIP/Postal Code
1012
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan S Lasa, MD
Phone
(54911)40848182
Email
drjuanslasa@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Impact of Diet on Capsule Endoscopy
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