The Effect of a Very Low-residual Diet on the Preparation Before Capsule Endoscopy

The aim of the proposed study is to compare prospectively two methods of small bowel preparation prior capsule endoscopy study, the effect on the cleanliness and the quality of visualization after two protocols of preparation: a 12 hour fast only versus 24 hour of a very low residual diet (ENSURE, Abbott Laboratories, Israel) + 12 hour fast.

Study Overview

• Status: Unknown
• Conditions: Gastrointestinal Complaints
• Intervention / Treatment: Dietary supplement: 24-hour low-residual diet

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eva Niv, MD; Phone Number: 972-4-630-4408; Email: evan@hy.health.gov.il

Study Locations

• Israel
  • Hadera, Israel, 38100
    • Hillel Yaffe Medical Center
    • Principal Investigator: Eva Niv, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Consecutive patients who will submitted to capsule endoscopy due to following medical indications:

  • suspected Crohn's disease
  • obscure GI bleeding
  • iron deficiency anemia
  • suspected malabsorption disease
  • unexplained abdominal pain
  • unexplained chronic diarrhea

Exclusion Criteria:

• pregnancy
• patients who had previous surgery on Gastrointestinal tract
• patients with previous intestinal obstruction
• patients who will refuse to participate in the study
• diabetes mellitus
• known celiac disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 12-hour fast
Active Comparator: 24-hour low-residual diet and 12-hour fast	Dietary supplement: 24-hour low-residual diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cleanliness and better visualization of the small bowel during capsule endoscopy	2 years

Collaborators and Investigators

• Sponsor: Hillel Yaffe Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: November 26, 2009
• First Submitted That Met QC Criteria: November 30, 2009
• First Posted (Estimate): December 1, 2009

Study Record Updates

• Last Update Posted (Estimate): December 1, 2009
• Last Update Submitted That Met QC Criteria: November 30, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Other Study ID Numbers: 0064-08-HYMC