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Immune Regulation in Ulcerative Colitis or Crohn s Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00001184
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : March 29, 2019
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Brief Summary:

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.

Condition or disease
Inflammatory Bowel Disease

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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of the Immune Regulation of Idiopathic Inflammatory Bowel Diseases: Crohn's Disease, Ulcerative Colitis, and Other Inflammatory Conditions of the Gut
Study Start Date : November 12, 1982

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. To identify the molecular abnormalities that result in inflammatory bowel diseases and develop novel therapies based on these discoveries. [ Time Frame: Ongoing ]

Secondary Outcome Measures :
  1. To enroll patients with IBD in order to obtain clinical, therapeutic, immunological, and genetic data relevant to the research study of their disease. [ Time Frame: ongoing ]
  2. To enroll patients with complicated, known IBD, unclassified/suspected IBD, or in a group at risk for IBD, but as yet subclinical (as in certain genetic syndromes) to undergo conventional diagnostic as well as research procedures in order to cla... [ Time Frame: ongoing ]
  3. To assess patients with IBD for their suitability for experimental treatment protocols. [ Time Frame: ongoing ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   8 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

    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;


    2. Patients with clinical features consistent with an unclassified inflammatory bowel disease and histologic evidence of inflammation of the intestine;


    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;


    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.


  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.


  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.


  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00001184

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Contact: Sandra M Maxwell, R.N. (240) 627-3078
Contact: Ivan J Fuss, M.D. (301) 496-9662

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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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Principal Investigator: Ivan J Fuss, M.D. National Institute of Allergy and Infectious Diseases (NIAID)

Additional Information:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00001184     History of Changes
Other Study ID Numbers: 820183
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: January 11, 2019

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Inflammatory Bowel Disease
Regional Enteritis
Crohn's Disease
Ulcerative Colitis

Additional relevant MeSH terms:
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Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes