- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03321669
Impact of Diet on Capsule Endoscopy
March 9, 2018 updated by: Juan Sebastian Lasa, Hospital Britanico
Impact of Diet on Capsule Endoscopy Transit Time - a Pilot Study
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Juan S Lasa, MD
- Phone Number: (54911)40848182
- Email: drjuanslasa@gmail.com
Study Locations
-
-
-
Buenos Aires, Argentina, 1012
- Recruiting
- Hospital Británico
-
Contact:
- Juan S Lasa, MD
- Phone Number: (54911)40848182
- Email: drjuanslasa@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult patients undergoing capsule endoscopy study
Exclusion Criteria:
- Not being able to follow a diet with increased amount of fat
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Increased Fat Diet
|
Ingestion of capsule endoscopy for the diagnosis of small bowel lesions
|
Sham Comparator: Low Fat Diet
|
Ingestion of capsule endoscopy for the diagnosis of small bowel lesions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Small bowel transit time
Time Frame: 12 hours
|
12 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 4, 2017
Primary Completion (Anticipated)
December 1, 2018
Study Completion (Anticipated)
December 1, 2018
Study Registration Dates
First Submitted
October 23, 2017
First Submitted That Met QC Criteria
October 23, 2017
First Posted (Actual)
October 26, 2017
Study Record Updates
Last Update Posted (Actual)
March 12, 2018
Last Update Submitted That Met QC Criteria
March 9, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HB764
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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