Low Fiber Diet for Bowel Preparation for Colon Capsule Examination

Overview

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

Full Title of Study: “A Prospective Randomized Controlled Investigator-blinded Study of Low Fiber Diet for Bowel Preparation for Colon Capsule Examination”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: Single (Investigator)
  • Study Primary Completion Date: July 2009

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: 1
    • Low fiber diet for 5 days prior to procedure
  • Active Comparator: 2
    • regular diet

Clinical Trial Outcome Measures

Primary Measures

  • Colon cleanliness
    • Time Frame: one week from capsule examination

Secondary Measures

  • Tolerability of preparations
    • Time Frame: within 1 day of completing preparation

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 50 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sheba Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Prof. Shomron BenHorin, Professor – Sheba Medical Center

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.