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Evaluation of People With Gastrointestinal Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01639924
First received: July 11, 2012
Last updated: March 14, 2014
Last verified: February 2014
  Purpose

Background:

- Gastrointestinal diseases and disorders affect the throat, stomach, and intestines. There are many different kinds of these diseases. Clinical trials are being developed to study new ways to treat them. People who are interested in clinical trials need to be screened before they can take part in the studies. Researchers want to evaluate people with different stomach and intestine disorders to see if they are eligible for clinical trials.

Objectives:

- To study people who have gastrointestinal disorders and see if they are eligible for clinical trials.

Eligibility:

- Individuals at least 18 years of age who have or may have a gastrointestinal disorder.

Design:

  • Participants will be screened with a physical exam and medical history. Blood, urine, and stool samples will be collected. Imaging studies such as x-rays and ultrasound will check to see if the disorder has affected other organs.
  • Participants may have tests as needed depending on their disorder. These tests include the following:
  • Colonoscopy and endoscopy of the large intestine, esophagus, and stomach.
  • Stomach acid analysis to look at stomach pH levels.
  • Wireless capsule endoscopy to take pictures of the small intestine.
  • Hydrogen breath testing to study issues like bloating, diarrhea, and constipation.
  • Sitz Marker Study to see how fast stool moves through the colon.
  • Participants may donate extra blood, urine, or stool samples for study. They may also donate stomach contents or tissue from the gut.
  • Treatment will not be provided as part of this study. However, participants may be admitted to other clinical trials.

Condition
Gastrointestinal Diseases

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation of Patients With Gastrointestinal Disease

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Evaluate patients with gastrointestinal disorders.

Secondary Outcome Measures:
  • During a clinically indicated standard of care test or procedure, allow for donation of extra stool, urine, blood, gastric aspirate or gastrointestinal tissue sample for collection and storage.
  • Allow outpatient evaluation and follow-up of patients with a variety of gastrointestinal diseases for the purposes of physician education in the NIDDK accredited gastroenterology training program.

Estimated Enrollment: 999999
Study Start Date: June 2012
Detailed Description:

Patients with suspected or established acute or chronic gastrointestinal diseases are evaluated and treated in this protocol and will be screened for entry into other research protocols. This protocol serves several purposes: 1) allows for detailed inquiry into the gastrointestinal disorders of these patients and the status of other organ systems that would determine their ability to safely enroll in active Digestive Diseases Branch (DDB) research protocols; 2) allows investigators to offer clinical diagnostic testing, procedures, and treatment to patients if clinically indicated to facilitate their participation in clinical trials; 3) allows outpatient evaluation and treatment of patients with a variety of gastrointestinal diseases for the purposes of physician education in our accredited gastroenterology training program; and 4) After completion of the initial evaluation process, patients will either be offered a chance to participate in an active research protocol or, if no appropriate protocol is identified, patients may be seen long-term to follow the disease progression for potential future participation in DDB gastrointestinal studies. Recommendations for other treatment options outside of the NIH will be discussed with study patients and/or to their primary or referring physicians.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • Known or suspected gastrointestinal disorders
  • Patients greater than or equal to 18 years of age capable of providing informed consent.
  • Existence of a referring community physician who would be able to manage care outside of the NIH.

EXCLUSION CRITERIA:

  • Significant medical illnesses that the investigators feel may interfere with potential evaluations.
  • 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 patient.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01639924

Contacts
Contact: Stephen A Wank, M.D. (301) 496-4202 stevew@bdg10.niddk.nih.gov

Locations
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 Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Stephen A Wank, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT01639924     History of Changes
Other Study ID Numbers: 120154, 12-DK-0154
Study First Received: July 11, 2012
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Small Bowel Disease
Digestive Disease
Upper GI Disease
Gastrointestinal Disease
Lower GI Disease

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on October 20, 2014