| City: |
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Bethesda |
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State:
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MD |
| Zip Code: |
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20892 |
| Conditions: |
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Crohn's Disease - Inflammatory Bowel Disease - Ulcerative Colitis |
| Purpose: |
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This study will investigate in patients with Crohn's disease and ulcerative colitis how the
body's immune system controls inflammation in the gastrointestinal tract (stomach and
intestines)-specifically, how lymphocytes (a type of white blood cell) function in
inflammatory responses. This protocol does not involve any experimental treatments.
Patients between the ages of 8 and 75 years of age with Crohn's disease or ulcerative
colitis or symptoms of inflammatory bowel disease may be eligible for this study. Screening
tests may include the following: medical history and physical examination, routine blood
tests, examination of stool specimens, X-rays such as barium enema or upper GI series,
proctosigmoidoscopy, colonoscopy, gastroduodenoscopy, and small bowel biopsy.
Participants will receive medical treatment according to the best generally accepted
measures for treating Crohn's disease or ulcerative colitis. This may include
anti-inflammatory drugs, immunosuppressive drugs, and antibiotics to treat infections. A
surgical consultation may be recommended for patients whose disease does not respond to
medical treatment. If surgery to remove intestinal tissue is recommended, a qualified
gastrointestinal surgeon will perform the procedure.
In addition, participants may undergo the following procedures:
- Blood drawing - No more than 450 milliliters (30 tablespoons, or 15 ounces) of blood
will be taken from adults over a 6-week period. A maximum of 7 ml (1/2 tablespoon) of
blood per kilogram (2.2. pounds) of body weight will be obtained from children within
the same time period, with no more than 3 ml/kg taken at any one time.
- Leukapheresis - This procedure is done to collect large quantities of white blood
cells. Whole blood is collected through a needle in an arm vein, similar to donating
blood. The blood is circulated through a machine that separates it into its components,
and the white cells are removed. The rest of the blood is returned to the body, either
through the same needle or through another needle in the other arm.
- Intestinal biopsies - Intestinal tissue will be obtained during colonoscopy with
intestinal biopsy in patients who require this procedure as part of their standard
medical care. Patients are given a sedative to reduce anxiety, but are conscious during
the procedure. A flexible tube is inserted into the rectum and large intestine,
allowing the physician to see the intestinal mucosa. At various places, small pieces of
tissue are plucked out.
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| Study summary: |
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This natural history protocol provides for the evaluation of patients with idiopathic
inflammatory bowel disease (ulcerative colitis, Crohn's disease, IBD associated with
immunodeficiency and genetic diseases, such as chronic granulomatous disease and
Hermansky-Pudlak syndrome, and additional undefined inflammatory conditions of the gut)
either on an inpatient or outpatient basis. The purpose of this protocol is to assess the
extent and activity of the disease in such patients, conduct immunologic studies of
lymphocyte and antigen-presenting cells derived from peripheral blood and tissues,
administer and monitor treatments, and study the genetic risk factors for these diseases.
This study will also be used to provide a mechanism for procurement of intestinal samples
obtained at sites outside the NIH at the time of medically indicated surgical or endoscopic
procedures from patients with IBD. In addition, it will allow for the procurement (send-in)
of blood for both immunological studies as well as DNA preparation as more IBD
susceptibility genes are discovered and we further our work on association of genetic
polymorphisms/mutations with the phenotype and immune abnormalities observed in our IBD
patients. This protocol will also allow for the procurement of blood and tissue samples from
healthy volunteers (without IBD) here at the NIH to use as a control group in comparison to
the immunologic and genetic data we obtain from the IBD patients that are enrolled. The
immediate aims of these studies are to define the immunologic abnormalities present and to
identify genetic susceptibility factors in patients with these diseases. The long term goal
of this protocol is to identify specific targets for development of novel therapeutics for
inflammatory bowel diseases. |
| Criteria: |
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- INCLUSION CRITERIA:
1. Patients with verifiable diagnosis of Crohn's disease, ulcerative colitis, or
IBD known to be associated with a co-existing condition and which is supported
by characteristic features, radiographic or endoscopic findings, or consistent
histopathologic mucosal changes;
OR
2. Patients with clinical features consistent with an unclassified inflammatory
bowel disease and histologic evidence of inflammation of the intestine;
OR
3. Patients with any clinical features consistent with inflammatory bowel disease
(intestinal inflammation), including but not limited to abdominal pain,
fistulae, weight loss, diarrhea, hematochezia or melena or suggestive
extra-intestinal symptoms (pyoderma, erythema nodosum, axial and articular
arthralgias, uveitis, fatigue, fever), in which a diagnosis has not been
verified;
OR
4. Patients who have a defined genetic syndrome linked to inflammatory bowel
disease risk with or without symptoms or findings consistent with IBD.
5. All subjects to be enrolled will be age 8 through 75 (but greater than or equal
to 18 years old for Hermansky-Pudlak syndrome patients).
6. To participate in the research biopsies during endoscopy, subjects must have the
following lab values within two weeks of the procedure:
Hematocrit greater than or equal to 30%
Platelet count greater than 100,000
PT INR less than or equal to 1.3 or PTT prolonged by less than or equal to 3
seconds
7. Ability to consent to the protocol on their own.
EXCLUSION CRITERIA:
1. Failure to meet the inclusion criteria.
2. Any medical, psychiatric, or social conditions which, in the opinion of the
investigators, would make participation in this protocol not in the best interest of
the subject.
NOTE: Pregnant patients are not excluded from enrolling in this natural history protocol,
but they are excluded from research procedures such as pheresis, more than 100 ml
venipuncture volumes within 6 weeks, and research endoscopies. However, they are eligible
for and tests or procedures that are medically-indicated and can be done with minimal risk
to the fetus.
INCLUSION CRITERA FOR HEALTHY VOLUNTEERS:
1. Must be willing to undergo blood draw and/or upper endoscopy and colonoscopy with
biopsy to obtain material for research purposes
2. Must be > 18 years old
3. Must be willing to submit samples for storage
EXCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:
1. History of inflammatory bowel disease.
2. Acute systemic or intestinal infection requiring antibiotics
3. Any condition that, in the investigator's opinion, places the patient at undue risk
by participating in the study |
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| Study is available at: |
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National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, MD 20892
United States
Primary Contact:
Patient Recruitment and Public Liaison Office
Email: prpl@mail.cc.nih.gov
Phone: (800) 411-1222 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 21, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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