Low Fiber Diet for Bowel Preparation for Colon Capsule Examination

Sheba Medical Center

Status and phase: Terminated; Phase 2

Conditions: Colon Preparation

Treatments: Other: low fiber diet; Other: regular diet

Study type: Interventional

Funder types: Other

Identifiers

NCT00749905

SHEBA-08-5217-SBH-CTIL

Details and patient eligibility

About

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

Enrollment: 75 estimated patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 2 patient groups

1

Experimental group

Description:

Low fiber diet for 5 days prior to procedure

Treatment:

Other: low fiber diet

2

Active Comparator group

Description:

regular diet

Treatment:

Other: regular diet