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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01022385
Recruitment Status : Unknown
Verified November 2009 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 1, 2009
Last Update Posted : December 1, 2009
Information provided by:
Hillel Yaffe Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Complaints Dietary Supplement: 24-hour low-residual diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Diagnostic
Study Start Date : December 2009
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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

Primary Outcome Measures :
  1. Cleanliness and better visualization of the small bowel during capsule endoscopy [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01022385

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Contact: Eva Niv, MD 972-4-630-4408

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Hillel Yaffe Medical Center
Hadera, Israel, 38100
Principal Investigator: Eva Niv, MD         
Sponsors and Collaborators
Hillel Yaffe Medical Center
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Responsible Party: Dr. Eva Niv, Hillel Yaffe Medical Center Identifier: NCT01022385    
Other Study ID Numbers: 0064-08-HYMC
First Posted: December 1, 2009    Key Record Dates
Last Update Posted: December 1, 2009
Last Verified: November 2009