NCT03321669

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 4, 2017

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 26, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 12, 2018

Status Verified

March 1, 2018

Enrollment Period

1.2 years

First QC Date

October 23, 2017

Last Update Submit

March 9, 2018

Conditions

Small Bowel Disease

Outcome Measures

Primary Outcomes (1)

  • Small bowel transit time

    12 hours

Study Arms (2)

Increased Fat Diet

ACTIVE COMPARATOR
Procedure: Capsule endoscopy

Low Fat Diet

SHAM COMPARATOR
Procedure: Capsule endoscopy

Interventions

Capsule endoscopyPROCEDURE

Ingestion of capsule endoscopy for the diagnosis of small bowel lesions

Increased Fat DietLow Fat Diet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients undergoing capsule endoscopy study

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Britanico

Buenos Aires, 1012, Argentina

RECRUITING

MeSH Terms

Interventions

Endoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Juan S Lasa, MD

CONTACT

(54911)40848182drjuanslasa@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 23, 2017

First Posted

October 26, 2017

Study Start

October 4, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

March 12, 2018

Record last verified: 2018-03

Locations

AR(1)