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
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