Immune Regulation in Ulcerative Colitis or Crohn s Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Colitis, Irritable Bowel Syndrome (IBS), Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 8 - 75 |
| Updated: | 3/31/2019 |
| Start Date: | November 12, 1982 |
| Contact: | Sandra M Maxwell, R.N. |
| Email: | maxwells@mail.nih.gov |
| Phone: | (240) 627-3078 |
Study of the Immune Regulation of Idiopathic Inflammatory Bowel Diseases: Crohn's Disease, Ulcerative Colitis, and Other Inflammatory Conditions of the Gut
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.
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.
This natural history protocol provides for the evaluation of patients with idiopathic
inflammatory bowel diseases (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.
inflammatory bowel diseases (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.
- INCLUSION CRITERIA:
1. Patients with a 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 clinical 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 between ages 8-75 (but greater than or equal
to 18 years old for Hermansky-Pudlak syndrome patients or subjects without IBD).
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 the IBD natural history
protocol, but they are excluded from research procedures such as pheresis, more than 100 ml
venipuncture volumes within 8 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
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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