The Effect of a Very Low-residual Diet on the Preparation... | NCT01022385

Studies
The Effect of a Very Low-residual Diet on the Preparation Before Capsule Endoscopy

NCT01022385

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Dec 1, 2009Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Gastrointestinal Complaints

Interventions

24-hour low-residual 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

Nov 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

Dec 2011Estimated

Completion Date

Dec 2011Estimated

First Submitted Date

Nov 26, 2009

First Submission Date that Met QC Criteria

Nov 30, 2009

First Posted Date

Dec 1, 2009Estimated

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

Nov 30, 2009

Last Update Posted Date

Dec 1, 2009Estimated

Description Module

Brief Summary

The aim of the proposed study is to compare prospectively two methods of small bowel preparation prior capsule endoscopy study, the effect on the cleanliness and the quality of visualization after two protocols of preparation: a 12 hour fast only versus 24 hour of a very low residual diet (ENSURE, Abbott Laboratories, Israel) + 12 hour fast.

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

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
12-hour fast	No Intervention
24-hour low-residual diet and 12-hour fast	Active Comparator		Dietary Supplement: 24-hour low-residual diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
24-hour low-residual diet	Dietary Supplement		24-hour low-residual diet and 12-hour fast

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cleanliness and better visualization of the small bowel during capsule endoscopy		2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Consecutive patients who will submitted to capsule endoscopy due to following medical indications:
- suspected Crohn's disease
- obscure GI bleeding
- iron deficiency anemia
- suspected malabsorption disease
- unexplained abdominal pain
- unexplained chronic diarrhea

Exclusion Criteria:

pregnancy
patients who had previous surgery on Gastrointestinal tract
patients with previous intestinal obstruction
patients who will refuse to participate in the study
diabetes mellitus
known celiac disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eva Niv, MD	Contact	972-4-630-4408		evan@hy.health.gov.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe Medical Center		Hadera		38100	Israel