NIH Clinical Research Studies

Protocol Number: 01-I-0153

Active Accrual, Protocols Recruiting New Patients

Title:
The Immune Basis for the Gastrointestinal Complications of Common Variable Immunodeficiency
Number:
01-I-0153
Summary:
This study will determine whether people with common variable immunodeficiency (CVID) with and without gastrointestinal (GI) symptoms have gut abnormalities (inflammation or loss of function) and changes in immune system cells and chemicals in the blood and gut. People with CVID have decreased levels of serum immunoglobulin IgG and IgA. Patients have sinus, lung and other infections, and many also have stomach and intestinal problems, such as chronic diarrhea, inability to absorb nutrition from food, and intestinal infections caused by bacteria.

CVID patients with gastrointestinal symptoms 10 years of age and older may be eligible for this study; CVID patients without gastrointestinal symptoms 18 years of age and older will be enrolled as control subjects. Candidates will be screened with a review of their medical records, a medical history and physical examination, HIV blood test, stool sample, and hydrogen breath test. The breath test measures the amount of hydrogen in the breath after drinking sugar water, showing the digestive effects of bacteria in the upper intestine.

Participants will be admitted to the NIH Clinical Center for several days to undergo the following procedures:

- Medical history and physical examination

- Blood tests

- Urine and stool samples

- 48-hour stool fat collection - measures the amount of undigested fat in the stool to determine the ability of the gut to digest and absorb fat in the diet

- D-Xylose absorption test - measures the ability of a sugar compound to travel across the lining of the intestine to determine the ability of the gut to absorb nutrients

- Upper endoscopy - a thin flexible lighted tube is advanced through the mouth to evaluate the esophagus, stomach and beginning of the small intestine

- Lower endoscopy - a thin lighted tube is advanced through the rectum to evaluate the colon

Identification of GI abnormalities associated with changes in immune response in CVID patients will help in developing and testing new treatments for this disease.

Sponsoring Institute:
National Institute of Allergy and Infectious Diseases (NIAID)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): None

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)).

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 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.

Special Instructions: Currently Not Provided
Keywords:
Malabsorption
Endoscopy
Cytokine
Immunophenotype
Lymphocyte
Recruitment Keywords:
Common Variable Immunodeficiency
Gastrointestinal
Malabsorption
Conditions:
Common Variable Immunodeficiency
Investigational Drug(s):
None
Investigational Device(s):
None

Contacts:
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:
Schaffer FM, Palermos J, Zhu ZB, Barger BO, Cooper MD, Volanakis JE Individuals with IgA deficiency and common variable immunodeficiency sharepolymorphisms of major histocompatibility complex class III genesProc Natl Acad Sci U S A 1989 Oct;86(20):8015-9

Wagner DK, Wright JJ, Ansher AF, Gill VJ Dysgonic fermenter 3-associated gastrointestinal disease in a patient withcommon variable hypogammaglobulinemiaAm J Med 1988 Feb;84(2):315-8PMID: 3407657

Cunningham-Rundles C, Bodian C Common variable immunodeficiency: clinical and immunological features of 248patientsClin Immunol 1999 Jul;92(1):34-48PMID: 10413651

Active Accrual, Protocols Recruiting New Patients

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