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
  Purpose

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 Intervention Phase
Colon Preparation
Other: low fiber diet
Other: regular diet
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: A Prospective Randomized Controlled Investigator-blinded Study of Low Fiber Diet for Bowel Preparation for Colon Capsule Examination

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Colon cleanliness [ Time Frame: one week from capsule examination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability of preparations [ Time Frame: within 1 day of completing preparation ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: January 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00749905

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

No publications provided

Responsible Party: Simon Bar-Meir, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00749905     History of Changes
Other Study ID Numbers: SHEBA-08-5217-SBH-CTIL
Study First Received: September 8, 2008
Last Updated: July 21, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

ClinicalTrials.gov processed this record on April 17, 2014