Low Fiber Diet for Bowel Preparation for Colon Capsule Examination

Phase 2TerminatedNCT00749905

Sheba Medical Center75 enrolled

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Colon Preparation

Interventions

low fiber dietOTHER

Low fiber diet for 5 days prior to colon capsule

regular dietOTHER

Regular diet until 1 day before colon capsule

Eligibility

Sex: ALLMin age: 50 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Sheba Medical Center

Tel Litwinsky, Israel

Outcomes

Primary Outcomes

Colon cleanliness

Time frame: one week from capsule examination

Secondary Outcomes

Tolerability of preparations

Time frame: within 1 day of completing preparation

Data from ClinicalTrials.gov

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