Is NCT00001184 recruiting in Bethesda, MD?

Yes, NCT00001184 is currently recruiting participants at its Bethesda, MD location. This inflammatory bowel disease clinical trial is actively enrolling qualified participants.

How do I join the inflammatory bowel disease clinical trial in Bethesda?

To join this clinical trial in Bethesda, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Bethesda clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Inflammatory Bowel Disease Clinical Trial in Bethesda, MD

About This Inflammatory Bowel Disease Study in Bethesda

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.

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Who Can Participate

Inclusion Criteria

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

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

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

Patients who have a defined genetic syndrome linked to inflammatory bowel disease risk with or without symptoms or findings consistent with IBD

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).

To participate in the research biopsies during endoscopy, subjects must have the 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

Ability to consent to the protocol on their own. INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:

Must be willing to undergo blood draw and/or upper endoscopy and colonoscopy with biopsy to obtain material for research purposes.

Must be \>=18 years old.

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:

Neither participation nor refusal to participate will have an effect, either beneficial or adverse, on the participant s employment or work situation.

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

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.

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

Failure to meet the inclusion criteria.

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:

History of inflammatory bowel disease.

Acute systemic or intestinal infection requiring antibiotics

Any condition that, in the investigator s opinion, places the patient at undue risk by participating in the study.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Bethesda?

Yes, this clinical trial (NCT00001184) has an active research site in Bethesda, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Inflammatory Bowel Disease Treatment Options in Bethesda, MD

If you're searching for inflammatory bowel disease treatment options in Bethesda, MD, this clinical trial (NCT00001184) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Bethesda research site is actively enrolling participants for this clinical trial. You'll receive care from experienced inflammatory bowel disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all inflammatory bowel disease clinical trials near you to find additional studies recruiting in your area.

Inflammatory Bowel Disease Clinical Trial in Bethesda, MD

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