Impact of Diet on Capsule Endoscopy

• Sponsor: Hospital Britanico (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03321669
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 13.9
• Patients Per Site Per Month: 1.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Small Bowel Disease	Procedure: Capsule endoscopy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Impact of Diet on Capsule Endoscopy Transit Time - a Pilot Study
• Actual Study Start Date: Oct 4, 2017
• Anticipated Primary Completion Date: Dec 1, 2018
• Anticipated Study Completion Date: Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Increased Fat Diet	Procedure: Capsule endoscopy; Ingestion of capsule endoscopy for the diagnosis of small bowel lesions
Sham Comparator: Low Fat Diet	Procedure: Capsule endoscopy; Ingestion of capsule endoscopy for the diagnosis of small bowel lesions

Outcome Measures

Primary Outcome Measures

1. Small bowel transit time [12 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult patients undergoing capsule endoscopy study

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Britanico	Buenos Aires		Argentina	1012

Sponsors and Collaborators

• Hospital Britanico

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Juan Sebastian Lasa, Principal Investigator, Hospital Britanico
• ClinicalTrials.gov Identifier: NCT03321669
• Other Study ID Numbers: HB764
• First Posted: Oct 26, 2017
• Last Update Posted: Mar 12, 2018
• Last Verified: Mar 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Intestinal Diseases

Study Results

No Results Posted as of Mar 12, 2018