Colon Preparation
Conditions
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
Interventions
OTHERlow fiber diet
Low fiber diet for 5 days prior to colon capsule
OTHERregular diet
Regular diet until 1 day before colon capsule
Sponsors
Sheba Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Colon cleanliness | one week from capsule examination |
Secondary
| Measure | Time frame |
|---|---|
| Tolerability of preparations | within 1 day of completing preparation |
Countries
Israel
Outcome results
None listed