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Assessment of Pulmonary Involvement inUlcerative Colitis by Induced Sputum

This study has been completed.
Sponsor:
Information provided by:
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT00490048
First received: June 21, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  Purpose

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. )


Condition Intervention
Ulcerative Colitis
 Procedure: Induced sputum (inhalation of 3.5% saline)

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • lung involvment in Ulcerative colitis patients

Estimated Enrollment: 20
Study Start Date: June 2007
Study Completion Date: June 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00490048

Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
Principal Investigator: Zvi Fireman, MD Hillel- Yaffe Med. Ctr
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00490048     History of Changes
Other Study ID Numbers: ISUC.CTIL
Study First Received: June 21, 2007
Last Updated: June 21, 2007
Health Authority: Israel: Ministry of Health

Keywords provided by Hillel Yaffe Medical Center:
Ulcerative colits
lung
Induced sputum
Our aim to evaluate lung involvement in Ulcerative colitis patients by induced sputum

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013