Low Fiber Diet for Bowel Preparation for Colon Capsule Examination

Colon Preparation Clinical Trial

Official title:

A Prospective Randomized Controlled Investigator-blinded Study of Low Fiber Diet for Bowel Preparation for Colon Capsule Examination

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00749905
• Other study ID #: SHEBA-08-5217-SBH-CTIL
• Status: Terminated
• Phase: Phase 2
• Start date: January 2009
• Est. completion date: December 2009

Study information

• Verified date: June 2018
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 75
• Est. completion date: December 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Colon Preparation

Intervention

Other:
• low fiber diet
Low fiber diet for 5 days prior to colon capsule
• regular diet
Regular diet until 1 day before colon capsule

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Tel-Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colon cleanliness		one week from capsule examination
Secondary	Tolerability of preparations		within 1 day of completing preparation