Immune Regulation in Ulcerative Colitis or Crohn s Disease

• INCLUSION CRITERIA:

1. Patients with a verifiable diagnosis of Crohn s disease, ulcerative colitis, orIBD known to be associated with a co-existing condition and which is supportedby characteristic clinical features, radiographic or endoscopic findings, orconsistent histopathologic mucosalchanges OR

2. Patients with clinical features consistent with an unclassified inflammatorybowel 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 suggestiveextra-intestinal symptoms (pyoderma, erythemanodosum, axial and articular arthralgias, uveitis, fatigue, fever), in which adiagnosis has not been verified. OR

4. Patients who have a defined genetic syndrome linked to inflammatory boweldisease risk with or without symptoms or findings consistent with IBD

5. All subjects to be enrolled will be between ages 0-75 (Participants coming tothe NIH Clinical Center must meet age and weight requirements of the clinicalcenter, but > 18 must years old for patients without IBD and may be as young as 0-2 years old for mail-insamples).

6. To participate in the research biopsies during endoscopy, subjects must havethe following lab values within two weeks of the procedure:

• Hematocrit > 30%
• Platelet count > 100,000
• PT INR < 1.3 or PTT prolonged by < 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 withbiopsy to obtain material for research purposes.

2. Must be >=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, eitherbeneficial or adverse, on the participant s employment or work situation.

2. The NIH information sheet regarding NIH employee research participation will bedistributed to all potential subjects who are NIH employees.

3. The employee subject s privacy and confidentiality will be preserved in accordancewith NIH Clinical Center and NIAID policies, which define the scope and limitationsof the protections.

4. For NIH employee subjects, consent will be obtained by an individual independent ofthe employee s team. Those in a supervisory position to any employee and co-workersof the employee will not obtain consent. The protocol study staff will be trainedannually on obtaining potentially sensitive and private information from co-workersor subordinates. This training will be reinforced as needed, at weekly teammeetings.

EXCLUSION CRITERIA:

1. Failure to meet the inclusion criteria.

2. Any medical, psychiatric, or social conditions which, in the opinion of theinvestigators, would make participation in this protocol not in the best interest ofthe 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 riskby participating in the study.