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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01022385
Other study ID # 0064-08-HYMC
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 26, 2009
Last updated November 30, 2009
Start date December 2009
Est. completion date December 2011

Study information

Verified date November 2009
Source Hillel Yaffe Medical Center
Contact Eva Niv, MD
Phone 972-4-630-4408
Email evan@hy.health.gov.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 0
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
24-hour low-residual diet


Locations

Country Name City State
Israel Hillel Yaffe Medical Center Hadera

Sponsors (1)

Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cleanliness and better visualization of the small bowel during capsule endoscopy 2 years No