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Evaluation of People With Gastrointestinal Disease

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ClinicalTrials.gov Identifier: NCT01639924
Recruitment Status : Recruiting
First Posted : July 13, 2012
Last Update Posted : October 19, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:


- 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.


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


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


  • 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 or disease
Gastrointestinal Diseases

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.

Study Design

Study Type : Observational
Estimated Enrollment : 999999 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Patients With Gastrointestinal Disease
Study Start Date : June 18, 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Evaluate patients with gastrointestinal disorders. [ Time Frame: Ongoing ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: At Visit ]
  2. 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. [ Time Frame: Ongoing ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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.


  • 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

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 ClinicalTrials.gov identifier (NCT number): NCT01639924

Contact: Beverly E Niles (301) 451-0659 beverlyn.niles@nih.gov
Contact: Stephen A Wank, M.D. (301) 496-4202 stevew@bdg10.niddk.nih.gov

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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Stephen A Wank, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
More Information

Additional Information:
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT01639924     History of Changes
Other Study ID Numbers: 120154
First Posted: July 13, 2012    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: August 11, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ):
Small Bowel Disease
Digestive Disease
Gastrointestinal Disease
Lower GI Disease

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases