Low Fiber Diet for Bowel Preparation for Colon Capsule Examination

This study has been terminated.

(was not able to recruit enough patients)

Sponsor:

Information provided by:

Sheba Medical Center

ClinicalTrials.gov Identifier:

NCT00749905

First received: September 8, 2008

Last updated: July 21, 2010

Last verified: July 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	September 8, 2008
Last Updated Date	July 21, 2010
Start Date ^ICMJE	January 2009
Estimated Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 8, 2008)	Colon cleanliness [ Time Frame: one week from capsule examination ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00749905 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 8, 2008)	Tolerability of preparations [ Time Frame: within 1 day of completing preparation ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Low Fiber Diet for Bowel Preparation for Colon Capsule Examination
Official Title ^ICMJE	A Prospective Randomized Controlled Investigator-blinded Study of Low Fiber Diet for Bowel Preparation for Colon Capsule Examination
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
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Diagnostic
Condition ^ICMJE	Colon Preparation
Intervention ^ICMJE	Other: low fiber diet Low fiber diet for 5 days prior to colon capsule Other: regular diet Regular diet until 1 day before colon capsule
Study Arm (s)	Experimental: 1 Low fiber diet for 5 days prior to procedure Intervention: Other: low fiber diet Active Comparator: 2 regular diet Intervention: Other: regular diet
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Estimated Enrollment ^ICMJE	75
Completion Date	Not Provided
Estimated Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	50 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Israel

Administrative Information
NCT Number ^ICMJE	NCT00749905
Other Study ID Numbers ^ICMJE	SHEBA-08-5217-SBH-CTIL
Has Data Monitoring Committee	No
Responsible Party	Simon Bar-Meir, Sheba Medical Center
Study Sponsor ^ICMJE	Sheba Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Sheba Medical Center
Verification Date	July 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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