Evaluation of People With Gastrointestinal Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal, Digestive Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/27/2018 |
| Start Date: | June 18, 2012 |
| Contact: | Beverly E Niles |
| Email: | beverlyn.niles@nih.gov |
| Phone: | (301) 451-0659 |
Evaluation of Patients With Gastrointestinal Disease
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.
- 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.
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.
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.
- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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