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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014