Inflammatory Bowel Disease Clinical Trial in Bethesda MD
NCT00001184
| Observational
This study is looking to recruit 1000 Participants
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 0 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.
Details for the study
Brief Title
Immune Regulation in Ulcerative Colitis or Crohn s Disease
Official Title
A Natural History Study of the Immune Regulation of Idiopathic Inflammatory Bowel Diseases: Crohn's Disease, Ulcerative Colitis, and Other Inflammatory Conditions of the Gut
Brief Summary
This study will investigate in patients with Crohn s disease and ulcerative colitis how the
<br /> body s immune system controls inflammation in the gastrointestinal tract (stomach and
<br /> intestines)-specifically, how lymphocytes (a type of white blood cell) function in
<br /> inflammatory responses. This protocol does not involve any experimental treatments.
<br />
<br /> Patients between the ages of 0 and 75 years of age with Crohn s disease or ulcerative colitis
<br /> or symptoms of inflammatory bowel disease may be eligible for this study. Screening tests may
<br /> include the following: medical history and physical examination, routine blood tests,
<br /> examination of stool specimens, X-rays such as barium enema or upper GI series,
<br /> proctosigmoidoscopy, colonoscopy, gastroduodenoscopy, and small bowel biopsy.
<br />
<br /> Participants will receive medical treatment according to the best generally accepted measures
<br /> for treating Crohn s disease or ulcerative colitis. This may include anti-inflammatory drugs,
<br /> immunosuppressive drugs, and antibiotics to treat infections. A surgical consultation may be
<br /> recommended for patients whose disease does not respond to medical treatment. If surgery to
<br /> remove intestinal tissue is recommended, a qualified gastrointestinal surgeon will perform
<br /> the procedure.
<br />
<br /> In addition, participants may undergo the following procedures:
<br />
<br /> - Blood drawing - No more than 450 milliliters (30 tablespoons, or 15 ounces) of blood
<br /> will be taken from adults over a 6-week period. A maximum of 7 ml (1/2 tablespoon) of
<br /> blood per kilogram (2.2. pounds) of body weight will be obtained from children within
<br /> the same time period, with no more than 3 ml/kg taken at any one time.
<br />
<br /> - Leukapheresis - This procedure is done to collect large quantities of white blood cells.
<br /> Whole blood is collected through a needle in an arm vein, similar to donating blood. The
<br /> blood is circulated through a machine that separates it into its components, and the
<br /> white cells are removed. The rest of the blood is returned to the body, either through
<br /> the same needle or through another needle in the other arm.
<br />
<br /> - Intestinal biopsies - Intestinal tissue will be obtained during colonoscopy with
<br /> intestinal biopsy in patients who require this procedure as part of their standard
<br /> medical care. Patients are given a sedative to reduce anxiety, but are conscious during
<br /> the procedure. A flexible tube is inserted into the rectum and large intestine, allowing
<br /> the physician to see the intestinal mucosa. At various places, small pieces of tissue
<br /> are plucked out.
Detailed Description
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.
Outcome Measures
Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.
Primary
To identify the molecular abnormalities that result in inflammatory bowel diseases and develop novel therapies based on these discoveries.
observational
Study Criteria
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 0-75 (Participants coming to the
NIH Clinical Center must meet age and weight requirements of the clinical center,
but > 18 must years old for patients without IBD and may be as young as 0-2 years
old for mail-in
samples).
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.
INCLUSION CRITERIA 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 greater than or equal to 18 years old.
3. Must be willing to submit samples for storage.
INCLUSION OF EMPLOYEES IN THE NIH INTRAMURAL STUDIES:
NIH employees and members of their immediate families may participate in this protocol. We
will follow the Guidelines for the Inclusion of Employees in NIH Research Studies and will
give each employee a copy of the NIH information sheet on Employee Research Participation.
For NIH employees:
1. Neither participation nor refusal to participate will have an effect, either
beneficial or adverse, on the participant s employment or work situation.
2. The NIH information sheet regarding NIH employee research participation will be
distributed to all potential subjects who are NIH employees.
3. The employee subject s privacy and confidentiality will be preserved in accordance
with NIH Clinical Center and NIAID policies, which define the scope and limitations of
the protections.
4. For NIH employee subjects, consent will be obtained by an individual independent of
the employee s team. Those in a supervisory position to any employee and co-workers of
the employee will not obtain consent. The protocol study staff will be trained
annually on obtaining potentially sensitive and private information from co-workers or
subordinates. This training will be reinforced as needed, at weekly team meetings.
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.
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.
