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Low Fiber Diet for Bowel Preparation for Colon Capsule Examination

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ClinicalTrials.gov Identifier: NCT00749905
Recruitment Status : Terminated (was not able to recruit enough patients)
First Posted : September 9, 2008
Last Update Posted : July 22, 2010
Sponsor:
Information provided by:
Sheba Medical Center

Brief Summary:
A prospective randomized controlled investigator-blinded study to compare efficacy of low fiber diet for 5 days versus regular diet, both as adjunct to one day clear liquid diet and standard bowel preparation for colon capsule examination

Condition or disease Intervention/treatment Phase
Colon Preparation Other: low fiber diet Other: regular diet Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: A Prospective Randomized Controlled Investigator-blinded Study of Low Fiber Diet for Bowel Preparation for Colon Capsule Examination
Study Start Date : January 2009
Estimated Primary Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Low fiber diet for 5 days prior to procedure
Other: low fiber diet
Low fiber diet for 5 days prior to colon capsule
Active Comparator: 2
regular diet
Other: regular diet
Regular diet until 1 day before colon capsule



Primary Outcome Measures :
  1. Colon cleanliness [ Time Frame: one week from capsule examination ]

Secondary Outcome Measures :
  1. Tolerability of preparations [ Time Frame: within 1 day of completing preparation ]


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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >18 and <75
  • Colon study indicated for colo-rectal carcinoma screening
  • After colonoscopy for any indication failed due to technical causes
  • Patients who decline an indicated colonoscopy

Exclusion Criteria:

  • Significant heart failure (NYHA grade III-IV)
  • Renal failure (Creatinine > 1.2 mg/dl)
  • Known or suspected intestinal strictures
  • Known or suspected mesenteric adhesions
  • History suggestive of bowel obstruction
  • Vomiting and/or aspirations
  • Symptoms of dysphagia
  • Pace-maker or AICD implanted
  • Known allergy or intolerance to any of the study drugs
  • Pregnancy
  • Illicit drug abuse or alcoholism
  • Inability to provide an informed consent

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 ClinicalTrials.gov identifier (NCT number): NCT00749905


Locations
Israel
Sheba Medical Center
Tel-Hashomer, Israel
Sponsors and Collaborators
Sheba Medical Center

Responsible Party: Simon Bar-Meir, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00749905     History of Changes
Other Study ID Numbers: SHEBA-08-5217-SBH-CTIL
First Posted: September 9, 2008    Key Record Dates
Last Update Posted: July 22, 2010
Last Verified: July 2010