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Protocol Details

Evaluation of Patients with Gastrointestinal Disease

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000247-DK

Sponsoring Institute

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 120 Years

Referral Letter Required

No

Population Exclusion(s)

Children

Keywords

Digestive System Diseases;
Gastrointestinal Diseases;
Small Bowel Disease;
Upper GI Disease;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Lower GI Disease;
Gastrointestinal Diseases

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Diabetes and Digestive and Kidney Diseases

Background:

Ongoing and future research projects that study gastrointestinal diseases depend on access to biological samples and clinical data. Researchers want to study people who are seen and treated for these diseases. This may help them assess and treat these diseases better in the future.

Objective:

To collect data and samples from people being seen and/or treated for gastrointestinal problems at NIH, to use in future research.

Eligibility:

Adults aged 18 and older who have known or suspected gastrointestinal disorders or need screening, treatment, or follow-up per current medical guidelines.

Design:

Participants will be screened with a physical exam. Their medical records will be reviewed.

Participants will be seen by doctors based on the ailment they have. Their condition will be treated just like it would at a doctor s office. But the data and samples collected will be used for future research.

Participants may give blood, urine, and/or stool samples.

If participants have an endoscopy or colonoscopy as part of their standard care and samples are taken, they may be asked to give their leftover samples to NIH. Or, they may be asked to have extra samples taken for NIH to use. These samples may include gastric acid and/or tissue from the lining of the stomach or intestines. If samples are not taken as part of their standard care, they may be asked to have samples taken for NIH to use.

Data will be stored at NIH. The data systems are password protected. Samples will be coded.

Participants will take part in the study for as long as they agree to be seen for their disease.

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Eligibility

INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Male or female, aged >= 18 years of age

2. Known or suspected gastrointestinal disorders or requiring clinical screening, management and/or treatment and follow-up per current American Gastroenterological Association (AGA), American Society for Gastrointestinal Endoscopy (ASGE) or the American Association for the Study of Liver Disease (AASLD).

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Significant medical illnesses that the investigators feel may interfere with potential evaluations.

2. Absence of a referring community physician who would be able to manage care outside of the NIH.

3. 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.

4. Inability to provide informed consent.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Sheila Kumar, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIHBC 10 - CLINICAL CENTER BG RM 9C101
10 CENTER DR
BETHESDA MD 20892
(301) 496-9730
sheila.kumar@nih.gov

Beverly E. Niles
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health
Building 10
Room 5-2740
10 Center Drive
Bethesda, Maryland 20892
(301) 451-0659
beverly.niles@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT05041374

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