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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Hillel Yaffe Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01022385
First received: November 26, 2009
Last updated: November 30, 2009
Last verified: November 2009

November 26, 2009
November 30, 2009
December 2009
December 2011   (final data collection date for primary outcome measure)
Cleanliness and better visualization of the small bowel during capsule endoscopy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01022385 on ClinicalTrials.gov Archive Site
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The Effect of a Very Low-residual Diet on the Preparation Before Capsule Endoscopy
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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.

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Interventional
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Primary Purpose: Diagnostic
Gastrointestinal Complaints
Dietary Supplement: 24-hour low-residual diet
  • No Intervention: 12-hour fast
  • Active Comparator: 24-hour low-residual diet and 12-hour fast
    Intervention: Dietary Supplement: 24-hour low-residual diet
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
Not Provided
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
Yes
Contact: Eva Niv, MD 972-4-630-4408 evan@hy.health.gov.il
Israel
 
NCT01022385
0064-08-HYMC
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Dr. Eva Niv, Hillel Yaffe Medical Center
Hillel Yaffe Medical Center
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Not Provided
Hillel Yaffe Medical Center
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP