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Protocol Details

Evaluation of Patients with Gastrointestinal Disease

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

12-DK-0154

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
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Upper GI Disease;
Small Bowel Disease;
Digestive Disease;
Gastrointestinal Disease;
Lower GI Disease

Recruitment Keyword(s)

None

Condition(s)

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:

- 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.

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Eligibility

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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Stephen A. Wank, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
BG 10 RM 9C101
10 CENTER DR
BETHESDA MD 20814
(301) 496-4202
stevew@mail.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: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT01639924

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