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Home > "I" Clinical Trials Conditions > Inflammatory Responses in Normal Volunteers and Patients with Abnormal Immune Responses Inflammatory Responses in Normal Volunteers and Patients with Abnormal Immune Responses
Inflammatory Responses in Normal Volunteers and Patients with Abnormal Immune Responses
For Condition: Healthy,Inflammation,Vasculitis
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: This study will investigate the inflammatory response. People with abnormal regulation of inflammation and immune defects often have an exaggerated or depressed inflammatory response that results in poor healing of recurrent infections. This study will measure and compare amounts of inflammatory mediators (chemicals involved in the inflammatory response) in healthy normal volunteers and in patients with abnormal immune responses. Healthy normal volunteers and patients with host defense defects or excessive inflammation, as in vasculitis syndromes, may be eligible for this study. Patients must be between 6 and 65 years of age. Participants will have eight small blisters raised on the forearm using a gentle suction device. The top of the blisters will be removed with scissors and a plastic template will be placed over the blisters. The wells of the template will be filled with a salt solution or a mixture of the subject's serum (fluid part of the blood without cells) and a salt solution. Some blisters may be covered with coverslips-a small round piece of very thin sterilized glass-before adding the fluid. Blister fluid will be removed from the wells at 3, 5, 8, and 24 hours with a syringe and analyzed for inflammatory mediators. A scab will form over the blisters and fall off in about 2 weeks. Participants will have about 4 tablespoons of blood drawn in order to compare the inflammatory mediators in the blood with those in the blister fluid.
Details: Patients with abnormal regulation of inflammation and with host defense defects often have an exaggerated or depressed inflammatory response with resultant difficulty in healing of recurrent infections. Delayed healing can be manifested by either a delay in wound healing, granuloma formation along the incision line, or dehiscence of a partially healed wound without evidence of infection. We are interested in measuring the amount of inflammatory mediators such as C5a, leukotriene B4 and the following cytokines, including the interleukins, chemokines, tumor necrosis factor, interferon-gamma and neopterin in an experimentally induced inflammatory response using a well studied suction blister device. This protocol is designed to study mediators of inflammation inpatients with host defense defects as well as patients with excessive inflammation as in the vasculitis syndromes. The mediators will be measured by ELISA or radioimmunoassay and/or High Performance Liquid Chromatography. Each of the above mediators contribute to the inflammatory process and several are thought to be important in granuloma formation. If patients are found to have abnormal amounts of these mediators when compared to normal volunteers or patients with other abnormalities it will help us understand the basis for their disease and new therapeutic strategies. For example, this blister study allowed us to identify a patient subsequently shown to have IRAK4 deficiency.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Patients having or thought to have an immune defect and between the ages of 6 and 65 years (inclusive) are eligible to participate. Only healthy volunteers ages 18 to 65 years are eligible to participate. Though slight, it seems unreasonable to expose healthy minors to the discomfort or risks involved in this study. EXCLUSION CRITERIA: Other than age, there are no exclusions.
Total Enrollment: 200
Location and Contact Information:
National Institute of Allergy and Infectious Diseases (NIAID) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 900120; 90-I-0120
Study Start Date: April 24, 1990
Record last reviewed: April 28, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001257
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3. Glucocorticoid Effects on Cellular Cytokine Release
4. Cyclooxygenase Levels Following Surgery to Remove Third Molars (Wisdom Teeth)
5. Analysis of Bronchial Tissue and Fluid in Patients with Wegener's Granulomatosis
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Inflammatory Responses in Normal Volunteers and Patients with Abnormal Immune Responses
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