Impact of Diet on Capsule Endoscopy | NCT03321669

Studies
Impact of Diet on Capsule Endoscopy

NCT03321669

Sponsor

Hospital Britanico

Status

Unknown status

Last Update Posted

Mar 12, 2018Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Small Bowel Disease

Interventions

Capsule endoscopy

Countries

Argentina

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 4, 2017Actual

Primary Completion Date

Dec 1, 2018Estimated

Completion Date

Dec 1, 2018Estimated

First Submitted Date

Oct 23, 2017

First Submission Date that Met QC Criteria

Oct 23, 2017

First Posted Date

Oct 26, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2018

Last Update Posted Date

Mar 12, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Increased Fat Diet	Active Comparator		Procedure: Capsule endoscopy
Low Fat Diet	Sham Comparator		Procedure: Capsule endoscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Capsule endoscopy	Procedure	Ingestion of capsule endoscopy for the diagnosis of small bowel lesions	Increased Fat Diet Low Fat Diet

Measure	Description	Time Frame
Small bowel transit time		12 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients undergoing capsule endoscopy study

Exclusion Criteria:

Not being able to follow a diet with increased amount of fat

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Juan S Lasa, MD	Contact	(54911)40848182		drjuanslasa@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Britanico	Recruiting	Buenos Aires		1012	Argentina

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004724	Endoscopy

Ancestor Terms

ID	Term
D003949	Diagnostic Techniques, Surgical
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D019060	Minimally Invasive Surgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided