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

NCT ID: NCT01022385

Last Updated: 2009-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-12-31

Brief Summary

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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

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Conditions

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Gastrointestinal Complaints

Study Design

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Primary Study Purpose

DIAGNOSTIC

Study Groups

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12-hour fast

Group Type NO_INTERVENTION

No interventions assigned to this group

24-hour low-residual diet and 12-hour fast

Group Type ACTIVE_COMPARATOR

24-hour low-residual diet

Intervention Type DIETARY_SUPPLEMENT

Interventions

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24-hour low-residual diet

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hillel Yaffe Medical Center

Locations

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Hillel Yaffe Medical Center

Hadera, , Israel

Site Status

Countries

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Israel

Central Contacts

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Eva Niv, MD

Role: CONTACT

Phone: 972-4-630-4408

Email: [email protected]

Other Identifiers

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0064-08-HYMC

Identifier Type: -

Identifier Source: org_study_id