Low Fiber Diet for Bowel Preparation for Colon Capsule Examination

NCT00749905 | Terminated Phase 2

• 1 other identifier: SHEBA-08-5217-SBH-CTIL
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Colon Preparation

Outcome Measures

Primary Outcomes (1)

• Colon cleanliness

  one week from capsule examination

Secondary Outcomes (1)

• Tolerability of preparations

  within 1 day of completing preparation

Study Arms (2)

1

EXPERIMENTAL

Low fiber diet for 5 days prior to procedure

Other: low fiber diet

2

ACTIVE COMPARATOR

regular diet

Other: regular diet

Interventions

low fiber diet OTHER

Low fiber diet for 5 days prior to colon capsule

1

regular diet OTHER

Regular diet until 1 day before colon capsule

2

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, Israel

Location

MeSH Terms

Interventions

Diet

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 8, 2008
• First Posted: September 9, 2008
• Study Start: January 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 14, 2018

Record last verified: 2018-06

Locations

IL (1)