Back to resultsAssessment of Pulmonary Involvement inUlcerative Colitis by Induced Sputum
Primary Purpose
Ulcerative Colitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Induced sputum (inhalation of 3.5% saline)
Sponsored by
About this trial
This is an interventional screening trial for Ulcerative Colitis focused on measuring Ulcerative colits, lung, Induced sputum, Our aim to evaluate lung involvement in Ulcerative colitis patients by induced sputum
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
lung involvment in Ulcerative colitis patients
Secondary Outcome Measures
Full Information
NCT ID
NCT00490048
First Posted
June 21, 2007
Last Updated
June 21, 2007
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00490048
Brief Title
Assessment of Pulmonary Involvement inUlcerative Colitis by Induced Sputum
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
5. Study Description
Brief Summary
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. )
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Ulcerative colits, lung, Induced sputum, Our aim to evaluate lung involvement in Ulcerative colitis patients by induced sputum
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Induced sputum (inhalation of 3.5% saline)
Primary Outcome Measure Information:
Title
lung involvment in Ulcerative colitis patients
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zvi Fireman, MD
Organizational Affiliation
Hillel- Yaffe Med. Ctr
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
10710066
Citation
Fireman Z, Osipov A, Kivity S, Kopelman Y, Sternberg A, Lazarov E, Fireman E. The use of induced sputum in the assessment of pulmonary involvement in Crohn's disease. Am J Gastroenterol. 2000 Mar;95(3):730-4. doi: 10.1111/j.1572-0241.2000.01843.x.
Results Reference
result
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Assessment of Pulmonary Involvement inUlcerative Colitis by Induced Sputum
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