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Evaluation of People With Gastrointestinal Disease

NCT01639924 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2761

Last updated 2022-02-18

No results posted yet for this study

Summary

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.

Conditions

  • Gastrointestinal Diseases

Sponsors & Collaborators

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

    lead NIH

Principal Investigators

  • Sheila Kumar, M.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-27
Primary Completion
2022-02-15
Completion
2022-02-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01639924 on ClinicalTrials.gov