- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00490048
Assessment of Pulmonary Involvement inUlcerative Colitis by Induced Sputum
June 21, 2007 updated by: Hillel Yaffe Medical Center
Ulcerative colitis is a systemic disease we assume that extra intestinal involvement as we describein our study( Fireman Z, Osipov A, Kivity S, Kopelman Y, Sternberg A Fireman E: Assessment of pulmonary involvement in Crohn's disease by induced sputum.
Am J Gastroenterol 2000;95(30):730-734. )
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Twenty Ulcerative colitis patients and 20 control subjects (all nonsmokers) without respiratory symptoms will be tested.
The induce sputum by 20' inhalation of 3.5% saline using ultrasonic nebulizer.
Samples will studied by differential counts of 200 cells on cytopreps stained by Giemsa.
T-lymphocyte subset analyses were done by FACS using three monoclonal antibodies: CD3 = total T cells, CD4 = T helper cells, and CD8 = T suppressor-cytotoxic cells.
CD4/CD8 >2.5 was considered abnormal.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All the ulceratvive colitis patients without lung involvmentage 18-75 years of age
Exclusion Criteria:
- Pregnant women
- Non cooperative patients
- Smoker
- Lung disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
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lung involvment in Ulcerative colitis patients
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Zvi Fireman, MD, Hillel- Yaffe Med. Ctr
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Study Completion (Actual)
June 1, 2007
Study Registration Dates
First Submitted
June 21, 2007
First Submitted That Met QC Criteria
June 21, 2007
First Posted (Estimate)
June 22, 2007
Study Record Updates
Last Update Posted (Estimate)
June 22, 2007
Last Update Submitted That Met QC Criteria
June 21, 2007
Last Verified
June 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ISUC.CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.