Low Fiber Diet for Bowel Preparation for Colon Capsule Ex... | NCT00749905

Studies
Low Fiber Diet for Bowel Preparation for Colon Capsule Examination

NCT00749905

Sponsor

Sheba Medical Center

Status

Terminated

Last Update Posted

Jun 14, 2018Actual

Enrollment

75Estimated

Phase

Phase 2

Conditions

Colon Preparation

Interventions

low fiber diet
regular diet

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

was not able to recruit enough patients

Expanded Access Info

Start Date

Jan 2009Actual

Primary Completion Date

Jul 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Sep 8, 2008

First Submission Date that Met QC Criteria

Sep 8, 2008

First Posted Date

Sep 9, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2018

Last Update Posted Date

Jun 14, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Low fiber diet for 5 days prior to procedure	Other: low fiber diet
2	Active Comparator	regular diet	Other: regular diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
low fiber diet	Other	Low fiber diet for 5 days prior to colon capsule	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Colon cleanliness		one week from capsule examination

Secondary Outcomes

Measure	Description	Time Frame
Tolerability of preparations		within 1 day of completing preparation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba Medical Center		Tel Litwinsky			Israel

Intervention Browse Module

MeSH Terms

ID	Term
D004032	Diet

Ancestor Terms

ID	Term
D009747	Nutritional Physiological Phenomena
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided