Low Fiber Diet for Bowel Preparation for Colon Capsule Examination

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Colon Preparation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Low fiber diet for 5 days prior to procedure

Group Type EXPERIMENTAL

low fiber diet

Intervention Type OTHER

Low fiber diet for 5 days prior to colon capsule

2

regular diet

Group Type ACTIVE_COMPARATOR

regular diet

Intervention Type OTHER

Regular diet until 1 day before colon capsule

Interventions

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low fiber diet

Low fiber diet for 5 days prior to colon capsule

Intervention Type OTHER

regular diet

Regular diet until 1 day before colon capsule

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No