Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001184
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
1999-11-03
Brief Title:
Immune Regulation in Ulcerative Colitis or Crohn s Disease
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Natural History Study of the Immune Regulation of Idiopathic Inflammatory Bowel Diseases Crohns Disease Ulcerative Colitis and Other Inflammatory Conditions of the Gut
Status:
RECRUITING
Status Verified Date:
2024-10-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 12 tablespoon of blood per kilogram 22 pounds of body weight will be obtained from children within the same time period with no more than 3 mlkg 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
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 12 tablespoon of blood per kilogram 22 pounds of body weight will be obtained from children within the same time period with no more than 3 mlkg 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
Detailed Description:
This natural history protocol provides for the evaluation of patients with idiopathic inflammatory bowel diseases ulcerative colitis Crohns 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 polymorphismsmutations 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 82-I-0183 | None | None | None |