Immune System and Gut Abnormalities in Patients With Common Variable Immunodeficiency With and Without Gastrointestinal Symptoms
Common Variable Immunodeficiency
About this trial
This is an observational trial for Common Variable Immunodeficiency focused on measuring Malabsorption, Endoscopy, Cytokine, Immunophenotype, Lymphocyte, Common Variable Immunodeficiency, Gastrointestinal
Eligibility Criteria
INCLUSION CRITERIA: Must have a verifiable diagnosis of common variable immune deficiency specifically a decrease both in IgG and at least one other Ig isotype to below two standard deviations of normal control levels. Must be age 10 years old or older for patients with gastrointestinal symptoms or age 18 years or older in the absence of gastrointestinal symptoms. Must be free of active sinopulmonary or other infection at time of enrollment. Must have negative results on stool examination for culture of enteric pathogens (Salmonella, Shigella, Yersinia, Campylobacter, Vibrio, E. Coli O157/H7), Clostridia difficile toxin assay, enteric parasites and their ova (including Cryptosporidia, Cyclospora, Microsporidia and Giardia (by stool EIA)). Adults who are unable to provide initial or on-going consent may participate in this study. EXCLUSION CRITERIA: Absence of other antibody deficiency states including X-linked agammaglobulinemia, hyper IgM syndrome, selective deficiency of IgG subclass, and Ig heavy chain gene deletions. Use of immunomodulating drugs within the following times prior to enrollment: daily corticosteroids (4 weeks), azathioprine/6-MP, cyclosporine, methotrexate, or FK506 (3 months). The use of short-term or single dose corticosteroids as a pretreatment regimen for IVIG is acceptable. Positive test for anti-HIV. Significant systemic or major disease including congestive heart failure, coronary artery disease, cerebrovascular disease and pre-existing or recent onset CNS demyelinating disorder, pulmonary disease, renal failure, organ transplantation, decompensated liver disease, serious psychiatric disease, or malignancy that in the opinion of the investigator would preclude successful endoscopic evaluation. Pregnancy, to avoid endoscopies without a strictly therapeutic intent in this relatively high risk population.
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike